Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Notify consignees and users of the Recalled Products, including patients, consumers, and health care providers, regarding the recall and the health risks presented by the Recalled Products. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. Review the recommendations above with patients who use the recalled devices, including that for some patients, stopping use of the device may involve greater risk than continuing to use the recalled device. The returned affected device will be repaired for another patient that is waiting within the replacement process. 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. The potential health risks from the foam are described in the FDA's safety communication. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. 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 known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. Call us at +1-877-907-7508 to add your email. The .gov means its official.Federal government websites often end in .gov or .mil. 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. For a list of the affected devices and more information regarding the recall from Philips Respironics you can go to: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateChapters:00:00 Intro00:44 Find Your Serial Number01:49 Online Form06:05 Demand for CPAP MachinesShop Online: Our Store: https://sleeplay.comCPAP Machines: https://sleeplay.com/collections/cpap-machinesCPAP Masks: https://sleeplay.com/collections/cpap-masksCPAP Cleaning: https://sleeplay.com/collections/cpap-cleaningCPAP Supplies: https://sleeplay.com/collections/cpap-suppliesOxygen Therapy: https://sleeplay.com/collections/oxygen-therapyGo Social:Facebook: https://facebook.com/sleeplaygroundInstagram: https://instagram.com/sleeplaygroundTwitter: https://twitter.com/sleeplayground TikTok: https://tiktok.com/@sleeplaygroundBecome an Affiliate:https://sleeplay.refersion.com/affiliate/registrationFree Consultation:https://calendly.com/sleeplay/respiratory-therapist-consultation Koninklijke Philips N.V., 2004 - 2023. To decide on the next steps, discuss the benefits and risks based on your individual health situation with your health care provider, such as your primary care physician or sleep doctor. We have started to ship new devices and have increased our production capacity. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Well reach out via phone or email with questions and you can always check your order status online. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. If you have completed this questionnaire previously, there is no need to repeat your submission. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. There are currently no items in your shopping cart. Talk with your health care provider about using an inline bacterial filter, which may help to filter out pieces of PE-PUR foam, as indicated in the Philips recall notification. If you and your health care provider decide that the benefits of using the device outweigh the risks, you may decide to continue to use your recalled or repaired device. There were no reports of patient injury or death among those 30 MDRs. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + In the US, the recall notification has been. 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. Determining the number of devices in use and in distribution. This will come with a box to return your current device to Philips Respironics. endstream endobj 273 0 obj <>/Metadata 11 0 R/Pages 270 0 R/StructTreeRoot 18 0 R/Type/Catalog/ViewerPreferences 288 0 R>> endobj 274 0 obj <>/MediaBox[0 0 612 792]/Parent 270 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 275 0 obj <>stream The full report is available here. Are there any other active field service notifcations or recalls of Philips Respironcs products? Monitor Philips' actions related to the repair or replacement of impacted devices until Philips has met all requirements related to the conduct of their Class I recall and the Medical Device Quality System regulation. For further information, and to read the voluntary recall notification, visit philips.com/src-update. Philips Sleep and respiratory care. 2. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. A locked padlock Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. Lock If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. Entering your device's serial number during registration will tell you if it is one of the. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer. That will allow them place an order for your supplies. 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. endstream endobj startxref Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. VA clinical experts are working with the FDA and the manufacturer to understand those risks. Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. I was instructed to upload my prescription settings to Philips Respironics through DreamMapper and am experiencing issues. Our physicians have had many meetings with the manufacturer as well as with other sleep medicine practices, and we currently recommend the following: Call Philips Respironics at 1-877-907-7508 to register your device or register your device via the web at: https://www.philipssrcupdate.expertinquiry.com/ SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. 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. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. 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. 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 . Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand 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. I have general DreamMapper questions or DreamMapper connection issues. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. CHEST Issues Joint Statement in Response to Philips Device Recall . 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. Can we help? The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. See all support information Find out more about device replacement prioritization and our shipment of replacement devices. We are working hard to complete this recall and will stay incommunication with both you and your care team share the most up-to-date information. The .gov means its official.Federal government websites often end in .gov or .mil. The data collected will be used to help to prioritize remediation of those patients at higher risk. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. To register a new purchase, please have the product on hand and log into your My Philips account. Consult with your physician as soon as possible to determineappropriate 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, and the FDA will communicate those results to the public as soon as they are available. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. We may need more information from you or you may have other options available to you, including alternative replacement devices or financial payment, dependent on your specific situation. Please contact the Philips Customer Service team directly on 877-907-7508 for more assistance. Because the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021 recall of certain ventilators, BiPAP machines, and CPAP machines (Recalled Products), as follows: In addition, Philips, as a medical device manufacturer, must comply with all applicable laws and regulations, including quality system regulations (21 CFR Part 820). 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. You are about to visit the Philips USA website. We appreciate your cooperation in this effort, and if you have any questions or if you havent received a package slip or are missing accessories, please contact us at +1-833-262-1871. 0 You are about to visit the Philips USA website. Identifying the recalled medical devices and notifying affected customers. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. We may request contact information, date of birth, device prescription or physician information. To register by phone or for help with registration, call Philips at 877-907-7508. 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. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. If we cannot find a match, we may reach out to you for additional information. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. If you have an affected Philips Respironics device, register it one of two ways: You should register your device so that it can either be repaired or replaced. Apologize for any inconvenience. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. Hit enter to expand a main menu option (Health, Benefits, etc). To register your product, youll need to log in to your My Philips account. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers Keep your registration confirmation number. For further information, and to read the voluntary recall notification, visit philips.com/src-update. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. 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. Only clean your device according to the manufacturers recommendations. Cleaning, setup and return instructions can be found here. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. Dont have one? This recall is for issues related to deterioration of the sound abatement foam used in these devices and affects CPAP and BiLevel PAP devices manufactured before April 26, 2021. Because the FDA issued a notification order under section 518 (a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021. Philips Respironics states that the likelihood of foam breakdown is higher in devices that are more than three years old, are used in high heat (more than 95 degrees) and high humidity environments or that were routinely cleaned with an ozone cleaning device. 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. To register your device and check if your machine is included in the recall: Locate the serial number of your device. 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. We will keep the public informed as more information becomes available. Philips Respironics Sleep and Respiratory Care devices, If you haven't yet registered your device, Important update to Philips US recall notification, Philips has updated the US recall notification to align with the, * This is a recall notification for the US only, and a field safety notice for the rest of the world. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). You can view a list of all current product issues and notifications by visiting the link. 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. Eight of those reports were from the U.S. 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. UPDATE - December 22, 2022: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. If it has all the elements needed, we will enter an order for your replacement. 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. Share sensitive information only on official, 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 Clinical Centers of Excellence (CCEs) and the Nationwide Provider Network (NPN) are reviewing medical records and working with the Programs medical equipment providers to identify members using the recalled models. All rights reserved. On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. Create account Create an account Already have an account? Well start processing your replacement device order once: 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. You can log in or create one here. I need to change my registration information. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. The devices are used to help breathing. UPDATE - February 9, 2023: The FDA updated this safety communication to provide updated information about medical device reports (MDRs) that the FDA received from November 1, 2022, to December 31, 2022, and are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. In the US, the recall notification has been classified by the FDA as a Class I recall. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. 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