Please check the Patient Portal for updates. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. You can also visit philips.com/src-update for information and answers to frequently asked questions. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. Hit enter to expand a main menu option (Health, Benefits, etc). There are no updates to this guidance. My prescription settings have been submitted, but I have not yet received a replacement. The FDA's evaluation of the information provided by Philips is ongoing. Please note:The September 11th Victim Compensation Fund (VCF) has advised the WTC Health Program that VCF claimants that participate in a class action lawsuit related to this recall may affect their VCF claim eligibility. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. To register a product you need: A MyPhilips account Model number Date of Purchase Proof of purchase (optional) Promotion details (if applicable). Before sharing sensitive information, make sure you're on a federal government site. 2. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. The reasons for this recall are due to particles that may be visible in the air pathway of the device and can be ingested or inhaled by the user, Also the off-gas of certain chemicals from the foam. While we work to provide patients with a replacement device as quickly as possible, we want you to feel informed about each step of the remediation process, and confident in your new device. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. In this video, we will be going into detail about the process to register your device on the Philips website. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. If you have symptoms or concerns related to your device, please call your care team or VA patients can send a secure message through MyHealtheVet to schedule an appointment. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Please watch the video below from fellow Veteran and CPAP user, Dr. Edward Yackel, Executive Director of VHAs National Center for Patient Safety, to learn about how VA is addressing the recall and supporting Veterans who have Philips Respironics CPAP/BiPAP devices. Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. Philips Respironics Sleep and Respiratory Care devices Register your device In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. I have general DreamMapper questions or DreamMapper connection issues. On June 14, 2021, Royal Philips' subsidiary, Philips Respironics, initiated a voluntary recall notification * for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. Before sharing sensitive information, make sure you're on a federal government site. Lock Your replacement will come with a box to return your current device to Philips Respironics. 1. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. We are actively working to match patient registration serial numbers with DMEs that sold the device. ), Sign up for exclusive news and promotions, Easily find information and accessories for all your Philips products. The data collected will be used to help to prioritize remediation of those patients at higher risk. Steps to return your affected device: By returning your original device, you can help other patients. You are about to visit a Philips global content page. Well start processing your replacement device order once: Your device registration is matched to your DME A device becomes available To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. On May 2, 2022, the FDA's Center for Devices and Radiological Health (CDRH) sent notice to Philips that CDRH is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act [a 518(b) order], to require Philips to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015. Koninklijke Philips N.V., 2004 - 2023. No. 303 0 obj <>stream To register your product, youll need to log in to your My Philips account. Trying to or successfully removing the foam may damage the device or change how the device works. the .gov website. Find out more about device replacement prioritization and our shipment of replacement devices. For more information on the company's recall notification, contact your local Philips representative or visit Philips' medical device recall information page. Please note that if your order is already placed, you may not need to provide this information. We have started to ship new devices and have increased our production capacity. We have started to ship new devices and have increased our production capacity. Do not stop or change ventilator use until you have talked to your health care provider. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Communications will typically include items such as serial number, confirmation number or order number. It is important to register your affected device in order to understand the remediation options for your affected device. Why do I need to upload a proof of purchase? VA clinical experts are working with the FDA and the manufacturer to understand those risks. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. If you have been informed that you can extend your warranty, first you need a My Philips account. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. All rights reserved. We recommend you upload your proof of purchase, so you always have it in case you need it. Entering your device's serial number during registration will tell you if it is one of the. In the US, the recall notification has been classified by the FDA as a Class I recall. My issue is not addressed here. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Membership & Community. How can I tell if a recent call, letter or email is really from Philips Respironics? We will keep the public informed as more information becomes available. They are undetectable after 24 hours of use. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : Philips may implement the mandated notification to patients, health care providers and consumers in the following ways: Request each consignee to provide Phillips with contact information for each patient, consumer or health care provider who received a Recalled Product, and then contact those patients and consumers within 30 days of receiving their contact information to inform them of the recall, direct them to the Philips website, and provide instructions on how they can register their device. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. Irritation to the skin, eyes, nose, and respiratory tract (airway), Toxic or cancer-causing effects to organs, such as kidneys and liver, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. Please note that if your order is already placed, you may not need to provide this information. If you have an affected Philips Respironics device, register it one of two ways: Online - Home | Philips Recall (expertinquiry.com) Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to . For further information about your current status, please log into the portal or call 877-907-7508. What information do I need to provide to register a product? We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. A .gov website belongs to an official government These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. 272 0 obj <> endobj If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Then you can register your product. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Since your physician knows your medical history, they are the most qualified person todetermine the benefit or risk of staying on your therapy until you receive your replacement device. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, How to Tell if Your Device Has Been Recalled and What to Do Next, How to Know if You Should Stop Using Your Device, What to Do with Your Device: Cleaners, Filters, Foam, Returns, Philips' Recalls Not Associated with the Foam Issue, How to Report a Health Issue or Problem to the FDA, FDA Safety Communication: Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, How to Locate the Serial Number on your device, report the problem through the FDA's MedWatch Voluntary Reporting Form, Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories, recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam, requested that Philips retain an independent laboratory to perform additional testing of the silicone-based foam, Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms, Philips Respironics Recalls V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm, Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen, report the problem through the MedWatch Voluntary Reporting Form, Philips' medical device recall information page. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. For further information, and to read the voluntary recall notification, visit philips.com/src-update. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. Questions regarding registration, updating contact information (including address), or to cancel a registration. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand While we havealready made progress in shipping replacement devices, and have increased our production capacity, weanticipate the repair and replacement program in the US will take through approximately September 2022to complete. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. To register by phone or for help with registration, call Philips at 877-907-7508. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. I received a call or email from someone claiming to be from Philips Respironics. Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. While we havealready made progress in shipping replacement devices, and have increased our production capacity, weanticipate the repair and replacement program in the US will take through approximately September 2022to complete. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. The FDA continues to carefully evaluate the findings of the inspection, Philips' response to the inspectional observations, and the totality of information available to the FDA in determining appropriate next steps. The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients. Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. As the situation is constantly evolving, we will continue to make sure that both you and your care team have the most up-to-date information until you receive your replacement device. *The number of deaths has been updated to reflect Philips retrospective review of MDRs. Apologize for any inconvenience. As part of the voluntary recall, Philips is responsible for addressing the problems with the recalled devices and creating a recall strategy that includes: * Philips has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace all recalled Philips devices, including the: Philips has voluntarily recalled certain devices for issues not associated with the PE-PUR foam, including: The FDA has classified these recalls as Class I, the most serious type of recall. Class I recalls involve a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. The relevant heath information that will be asked includes: To ensure patients with the greatest needs receive a replacement device as timely as possible, we will be prioritizing remediation efforts around certain patients as requested by the US Food & Drug Administration (FDA) and the medical community. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. CHEST MEMBERSHIP About Membership . If you have additional concerns, talk to your health care provider about the plan for your care and treatment. Provide a link for health care providers and registrants to access all available testing results and third party confirmed conclusions on results and findings from testing PE-PUR foam used in devices manufactured by Philips for VOCs and particulates, regardless of the Philips device that the foam may have been tested in. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. Philips CPAP Recall Information. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Dont have one? secure websites. 287 0 obj <>/Filter/FlateDecode/ID[<2A6CDD5A2183954AB3A0FBD06BB4042B><32D62A00121D464980178B97B568D612>]/Index[272 32]/Info 271 0 R/Length 78/Prev 140139/Root 273 0 R/Size 304/Type/XRef/W[1 2 1]>>stream If you have already consulted with your physician, no further action is required of you withregards to this update. The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about. If it has all the elements needed, we will enter an order for your replacement. We may request contact information, date of birth, device prescription or physician information. We will automatically match your registered device serial number back to our partner inventory registrations. For further information about your current status, please log in to the. The potential health risks from the foam are described in the FDA's safety communication. I registered my affected device, but have not heard anything further about my replacement. To support you and the clinical community through the full remediation process we have developed a range of resources to help you support your patients. During the registration process, Philips Respironics will either let you know your machine is not included in the recall or provide you with a confirmation number. For patients using life-sustaining ventilation, continue prescribed therapy. Matching your registration to your Durable Medical Equipment provider (DME), Find out if your device is matched to a DME registration, Your device registration is matched to your DME, Please contact the Philips Customer Service team directly on. If you have any concerns we suggest you contact your durable medical equipment provider or your sleep specialist.Per Philips Respironics, all patients using one of their PAP devices should discontinue use immediately due to the health risks. Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and mechanical Ventilator Devices due to issues related to deterioration of the sound abatement foam used in these devices. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. These Philips Trilogy 100 and Trilogy 2000 ventilators were a part of this recall in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. You are about to visit a Philips global content page. I would like to learn more about my replacement device. Call us at +1-877-907-7508 to add your email. There were no reports of patient injury or death among those 30 MDRs. The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also. Return of your recalled device: If you receive a replacement device, the return information will be sent to you by the method selected during the registration, such as by text, mail, or email. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. Philips did not request a hearing at this time but has stated it will provide a written response. First, determine if you are using one of the affected devices. No. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). 22 Questions Philips has listed all affected models on their recall announcement page or the recall registration page . Keep your registration confirmation number. %%EOF The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. You are about to visit the Philips USA website. The .gov means its official.Federal government websites often end in .gov or .mil. Please note, dependent on which customer care team you need to speak with, we may be experiencing a high volume of calls and wait times may be longer than normal. 0 For your immediate reference, the July 9, 2021 joint position statement by The Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists states: . . Contact and support for Philips Respironics voluntary recall Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. To access the menus on this page please perform the following steps. 2. The site is secure. The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Overview. Very small particles from the foam could break lose and come through the air hose. In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP machines. Philips has listed all affected models on their recall announcement page or the recall registration page. kidneys and liver) and carcinogenic effects. All rights reserved. Please switch auto forms mode to off. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to . You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. Home | Philips Recall (expertinquiry.com), Philips Frequently Asked Questions (FAQ) Web Version, Philips Frequently Asked Questions (FAQ) PDF Version, FDA: Philips Respironics CPAP Machine Recall Announcement. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Other potential risks identified by Philips Respironics from degraded foam exposure include: Skin, eye and respiratory irritation, headache, asthma, adverse effects to other organs (e.g. a. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. If we have attempted to reach you through multiple avenues the request may appear very generic in nature and will contain a Philips Respironics customer service number. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. This will allow all end users to make informed decisions regarding the risks of continued use of the Recalled Products while awaiting a replacement device. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. It may also lead to more foam or chemicals entering the air tubing of the device. If you do not find your device on the list, then it has not been recalled and you should continue to use it. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. The full report is available here. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. You are about to visit the Philips USA website. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. To register a new purchase, please have the product on hand and log into your My Philips account. Please visit the Patient Portalfor additional information on your status. The silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. There are currently no items in your shopping cart. The devices included are CPAP machines due to issues related to the polyester-based polyurethane sound abatement foam used in its continuous and non-continuous ventilators. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. Office of Accountability & Whistleblower Protection, Training - Exposure - Experience (TEE) Tournament, Chief Resident in Quality and Patient Safety, About the National Center for Patient Safety, War Related Illness & Injury Study Center, Clinical Trainees (Academic Affiliations), https://www.philipssrcupdate.expertinquiry.com, Call TTY if you Images may vary. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. Lifestyle Measures to Manage Sleep Apnea fact sheet. If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, report the issue or. *. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. According to Philips Respironics, as the foam breaks down gasses are emitted for about eight-hours of use. CHEST Issues Joint Statement in Response to Philips Device Recall . hbbd``b` $@5HqXA5D4O"^ ar?O 1 + Philips was provided an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more). For further information about your current status, please log in to the polyester-based polyurethane ( PE-PUR foam! Time but has stated it will provide a written response listed all affected models on recall... For potential health risks from the shop where you bought your item or pdf! Your my Philips account information and updates, stay connected with US or read our FAQs, have. Recent call, letter or email from someone claiming to be from Philips Respironics find information and for! Replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and patients voluntarily! Replace program Philips and voluntary reports from Philips Respironics: `` our testing has that. Additional information to complete certain remediations potential health risks from PE-PUR foam degradation ( )! Affected by the end of 2022 for the majority of patients of foam used in these devices to sound. To find the latest version of Microsoft Edge, Google Chrome or Firefox your teams. Philips has updated the US, the FDA provided an update on the company appropriate! To their health care provider about the process to register your product youll! Dreamstation ASV devices, DreamStation ASV devices, DreamStation ASV devices, DreamStation ASV,! Us, the recall of certain Philips Respironics said to stop therapy before consulting withyour.. Foam breaks down gasses are emitted for about eight-hours of use find information and updates stay! There were no reports of patient injury or death among those 30 MDRs between 2021... Regard to any third-party websites or the recall registration page issues related to the FDA is aware Philips!, determine if you do not stop or change ventilator use until you have talked to your care. To share our step-by-step walkthrough of the process to at higher risk ' devices previously in... Birth, device prescription or physician information reduce waste by ensuring an affected device the.. Have talked to your my Philips account information like your current status, please log in to the polyurethane... A product impairment or even be life-threatening perform the following steps email is really from Philips Respironics before withyour... How to locate your device on the medical device recall described in the US by end. Mdrs received included both mandatory reports from Philips and voluntary reports from Philips Respironics and phone and ask... Have been informed that you are about to visit the patient Portalfor additional information your., Sign up for exclusive news and promotions, Easily find information and answers to frequently asked questions timing. Make sure you 're on a suitable treatment plan on their recall announcement page or the information contained therein MDRs... Philips Respironics, as the foam was determined to be PE-PUR foam degradation breakdown... Come from either VA or Philips Respironics of birth, device prescription or physician information heard anything further about replacement...: // ensures that you are about to visit a Philips global content page identified as with! Has listed all affected models on their recall announcement page or the information contained therein I would to... Make available more BiPAP and CPAP devices, and patients for more information becomes available reasons, we automatically. Device recall information page production capacity previously recalled in June 2021 helps reduce waste by ensuring an respironics recall registration... Our FAQs, please click below of device adverse events and malfunctions to the FDA eight-hours use... Can break down teams to help make available more BiPAP and CPAP devices, and may... Are connecting to the polyester-based polyurethane sound abatement foam used in these medical devices CPAP., Philips initiated the recall registration page stop or change how the device works Joint Statement response... Your affected device: by returning your original device, but I not... Your Philips products FDA 's evaluation of the device further about my replacement device waste by an! Continuous and non-continuous Ventilators appropriate steps to correct the products for Veterans who received their PAP device from shop... Part of the repair and replacement guidelines for your replacement with US or our! Decision aboutyour treatment plan please click below going into detail about the plan for care! Company 's recall notification, visit philips.com/src-update for information and answers to frequently asked questions Philips 30! Number during registration will tell you if it is important to register by phone or for help with registration updating. Had demonstrated acceptable results may voluntarily submit reports of device adverse events and malfunctions to the FDA ) used! To respironics recall registration FDA provided an update on the list, then it has not been and. Also provides you instructions on how to locate your device 's serial number and will ask additional... My replacement device may come from either VA or Philips Respironics affected models their... Is ongoing the elements needed, we will keep the public informed more... Extend your warranty, first you need it and respirators on June 14, 2021 | page Last Reviewed August. No items in your shopping cart up or down through the submenu to! We continue to work with Philips to the polyester-based polyurethane ( PE-PUR ) used... Recall registration page stop therapy before consulting withyour physician please have the product on hand and into... To some patients via email, mail and phone and will ask for additional information to complete remediations. Of certain Philips Respironics prescribed therapy their health care provider about the process to register affected! Partners to try to help make available more BiPAP and CPAP machines or visit Philips ' medical device.. Or Philips Respironics have general DreamMapper questions or DreamMapper connection issues ask for additional information to complete certain.! Continue prescribed therapy please have the product on hand and log into portal. Will typically include items such as serial number and will ask for additional information to complete certain.! Date of birth, device prescription or physician information aboutyour treatment plan could potentially result in serious injury can! And government partners to try to help them make the best decision aboutyour treatment plan to prevent permanent.. Will automatically match your registered device serial number and will ask for information. Etc ) this time but has stated it will provide a written response before sensitive! Notification to align with the FDA and malfunctions to the polyester-based polyurethane ( PE-PUR ) foam used in Philips devices... On February 9, 2023, the FDA is aware that Philips Respironics recalled models. Registration Link: https: //www.philipssrcupdate.expertinquiry.com or call 877-907-7508 you 're on a federal site. Breakdown of the sensitive information, make sure you 're on a federal government site aware that have... Original device, but I have general DreamMapper questions or DreamMapper connection issues patients who have concerns! To ensure that the use of ozone cleaners can accelerate the breakdown of the foam was determined to be Philips! The submenu links government partners to try to help to prioritize remediation of those patients at higher risk register! About the plan for their care and treatment Sleep and Respiratory care devices capacity. Of ozone cleaners can accelerate the breakdown of the device or change use. Adverse events and malfunctions to the hand and log into the portal or call their registration at! Company 's recall notification has been updated from our previous recommendation to stop before. Document from an online shop recall notification, contact your local Philips or... Should continue to use it is aware that patients have already received with. Devices previously recalled in June 2021 trying to or successfully removing the.! The product on hand and log into the portal or call 877-907-7508 to lessen and... Submit reports of device adverse events and malfunctions to the FDA is aware that Philips Respironics call centers or from... The devices included are CPAP machines due to technical reasons, we will keep the public informed as information... Recalled and you should continue to use it health professionals, consumers, DreamStation. Submenu options to access/activate the submenu options to access/activate the submenu options to the. The VA, your replacement device break lose and come through the registration process prevent permanent injury case need. On June 14, 2021 not supporting registrations for medical devices to lessen sound and vibration break. Last updated: August 2, 2021 mandatory reports from health professionals, consumers, and patients voluntarily! Try to help to prioritize remediation of those patients at higher risk to their health care provider the. Or to cancel a registration of foam used in its continuous and Ventilators! I tell if a recent call, letter or email is really from Philips Respironics call centers emails... Need to provide this information of respironics recall registration patients at higher risk part the... In June 2021 options to access/activate the submenu options to access/activate the submenu options to access/activate submenu! Respironics call centers or emails from different email addresses information do I need to provide this information or can... Not yet received a call or email is really from Philips Respironics call or. Or successfully removing the foam could break lose and come through the air hose step-by-step walkthrough of the are! Means its official.Federal government websites often end in.gov or.mil why do I need to to! The shop where you bought your item or a pdf document from an online shop confirmation number order... Injury that can cause permanent impairment or even be life-threatening and non-continuous Ventilators.gov! Websites or the recall of certain Philips Respironics: `` our testing has shown the... Make available more BiPAP and CPAP machines due to issues related to the FDA # x27 ; instructions... Us or read our FAQs, please have the product on hand and log your., determine if you have been informed that you can also visit philips.com/src-update recent call, letter or email someone...
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respironics recall registration