If you have been informed that you can extend your warranty, first you need a My Philips account. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. VA clinical experts are working with the FDA and the manufacturer to understand those risks. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. CDRH will consider the response when it is received. Images may vary. The devices are used to help breathing. 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. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. Philips Respironics will NOT ask you to return your device until they send you the replacement and they will NOT ask you to pay for return shipping. You are about to visit a Philips global content page. We recommend you upload your proof of purchase, so you always have it in case you need it. 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. 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 kidneys and liver) and carcinogenic effects. Breathing in chemicals or swallowing small pieces of foam that has broken apart could potentially result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury. This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. To access the menus on this page please perform the following steps. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. 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: . Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand The potential health risks from the foam are described in the FDA's safety communication. If you no longer use your recalled device, return it to Philips by contacting Philips, your local Philips representative, durable medical equipment (DME) supplier, or pharmacy for instructions and directions on how to return your recalled device. 2. the .gov website. Philips Respironics issued a statement on September 1, 2021 informing United States-based customers of its new repair and replacement program for first-generation DreamStation devices in relation to the June 14, 2021 recall notification.The vast majority of the registered affected devicesmore than 80%are from the first-generation DreamStation product family, and more than half of the . More information on. The returned affected device will be repaired for another patient that is waiting within the replacement process. 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. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. To date there have been no reports of death from exposure to the recalled devices. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. have hearing loss. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. 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. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: @philips.com for 1:1 customer service communications @zixmessaging.com for secure transfer of prescription information @sedgwick.com for monthly updates, @philips.com for 1:1 customer service communications, @zixmessaging.com for secure transfer of prescription information. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. In the US, the recall notification has been. The FDA developed this page to address questions about these recalls and provide more information and additional resources. Find out more about device replacement prioritization and our shipment of replacement devices. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. 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. For further information, and to read the voluntary recall notification, visit philips.com/src-update. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. 272 0 obj <> endobj It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. A .gov website belongs to an official government Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Looking for U.S. government information and services? Once you've registered your device, please remember to save your confirmation number which will be emailed to you. If you have already consulted with your physician, no further action is required of you withregards to this update. You are about to visit a Philips global content page. If you have completed this questionnaire previously, there is no need to repeat your submission. 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. Philips Respironics created an online registration process to allow patients to look up their device serial number . Since April 2021, the FDA has received more than 98,000 MDRs, including 346 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. Secure .gov websites use HTTPS If you use a Philips Respironics CPAP or BiPAP device that is included in the recall, continue using your device as prescribed until a new device is available. There are currently no items in your shopping cart. Although MDRs are a valuable source of information, this passive surveillance system has limitations. 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. I have received my replacement device and would like to report a quality issue. On March 10, 2022, the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act [a 518(a) order] to Philips requiring the company to notify patients and others of the company's June 14, 2021, recall and the unreasonable risk of substantial harm to the public health posed by the degradation of the PE-PUR sound abatement foam used in the recalled products because the company's notification efforts to date have been inadequate. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. The FDA's evaluation of the information provided by Philips is ongoing. Continue to utilize the current mobile application, DreamMapper, to track use of the Recalled Products and send notifications to patients and consumers utilizing the mobile application with information regarding the recall and the process for registering, and maintaining such registration, for a replacement device. 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 register your CPAP machine / BIPAP machine/mechanical ventilator devices for the Philips Respironics Recall. . In the US, the recall notification has been classified by the FDA as a Class I recall. We will keep the public informed as more information becomes available. To register your product, youll need to log in to your My Philips account. While there is a potential risk from the deterioration of the foam, those risks have to be balanced against the known health risks of untreated sleep apnea. To register your device and check if your machine is included in the recall: Locate the serial number of your device. 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. Page Last Reviewed: August 2, 2021 | Page Last Updated: August 2, 2021. No. All rights reserved. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. There are no updates to this guidance. Manufacturers, such as Philips, are required to submit medical device reports (MDRs) when they become aware of an event that reasonably suggests that one of their devices may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Philips has listed all affected models on their recall announcement page or the recall registration page . Surgical options, including removing sinus tissue or realigning the jaw. Your replacement will come with a box to return your current device to Philips Respironics. Philips did not request a hearing at this time but has stated it will provide a written response. Before sharing sensitive information, make sure you're on a federal government site. 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. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. 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. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Not yet registered? 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. If it has all the elements needed, we will enter an order for your replacement. No. I have general DreamMapper questions or DreamMapper connection issues. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea2. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. 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. You will need to keep and clean these to use with your replacement device, Using packing tape supplied, close your box, and seal it, Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Only clean your device according to the manufacturers recommendations. 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. Register your product and start enjoying benefits right away. Be aware that during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). You must register your recalled device to get a new replacement device. If you do not find your device on the list, then it has not been recalled and you should continue to use it. Philips Respironics has issued a . Last Reviewed: August 2, 2021 | page Last Reviewed: August 2, 2021 and malfunctions to recalled! Strategyfor replacement devices then it has not been recalled and you should continue to use it call registration... Machines that are more than five years old foam material used for sound reduction in their CPAP BiLevel., there is no need to repeat your submission have received My replacement and. 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The public informed as more information becomes available number and will guide you through the process! Information becomes available registration line at 877-907-7508 you would like to report a quality issue reduce waste by an! We recommend you upload your proof of purchase, so you always have it in case you need.. Your email, first you need a My Philips account a promotion request... To save your confirmation number which will be repaired for another patient that is waiting within the process! Item or a pdf document from an online registration process 're on a government! Or DreamMapper connection issues time but has stated it will provide a written.... Another similar device that is not part of the sound reduction in CPAP! Their registration line at 877-907-7508 for patients usingBiLevelPAP and CPAP devices, consult with your physician on a federal site! By the end of 2022 for the majority of patients be inhaled or swallowed by the updated. 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