Learn more about Philips products and solutions for healthcare professionals. The recall and health risks have led people with sleep apnea to find Philips CPAP alternatives. We understand that this is frustrating and concerning for patients. Please click here for the latest testing and research information. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. In the alternative, obtain from each consignee documentation confirming that the consignee has provided, within 30 days of receiving Philips' notification, each patient, consumer or health care provider who received a Recalled Product with the Philips notification that informs them of the recall, directs them to Philips' website, and provides instruction on how they can register their device. This also includes an in-depth review and re-assessment of data and toxicological risk-assessments prior to June 2021. Phone. At the time, Philips Respironics could not exclude possible carcinogenic effects with the limited dataset that was available. As part of the remediation, we are offering repair or replacement of affected devices free of charge. Our trained service professionals can make sure that the affected foam is completely and safely removed, and that the new silicone foam is inserted correctly. With your replacement device reassembled and ready for use, return your affected device by placing it into the cardboard package in which you received your replacement device. For example, spare parts that include the sound abatement foam are on hold. Okie bipap. Please click here for the latest testing and research information. The health risks come from sound abatement foam used to keep the machines quiet and reduce vibration. It is also important that your DME provider work with Philips RS to ensure that we have the information required to be able to send you your replacement device. Alongside this, we have expanded our pool of experts in the areas of treatment and components, including specialists in toxicology, biocompatability and chemistry. Out of an abundance of caution, a reasonable worst-case scenario was considered. We appreciate your cooperation in this effort, and if you have any questions, please contact us at +1-833-262-1871. 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. Additionally, we remind both customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use. The American Academy of Sleep Medicine provides important safety information for patients about the Philips recall of certain PAP devices. Ozone cleaners may exacerbate the breakdown of the foam, and . Check the list of devices lower on this page to see if your device is affected by this action. Please click. Why cant I register it on the recall registration site? Devices affected by the recall / field safety notice must be serviced only by qualified technicians. We will share regular updates with all those who have registered a 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 recall also included many bilevel positive airway pressure (BiPAP) devices and ventilators designed to provide breathing assistance. The potential issue is with the foam in the device that is used to reduce sound and vibration. Philips will then confirm that your device is one of the recalled models and advise you about your next steps. September 7, 2021 / 7:22 AM / CBS News. Follow the manufacturers instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Working to reach everyone affected so they understand the situation and know what they need to do, starting with the registration of the affected devices. Further testing and analysis on other devices is ongoing. Also, be sure to keep all packaging materials, as they will be used to return your affected device back to Philips Respironics. While recalled devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and remediated devices is a different, silicone foam. Please be assured that we are doing all we can to resolve the issue as quickly as possible. What is the status of the Trilogy 100/200 remediation? Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. Whether in the judgement of the treating clinical team the benefit of continued usage of these ventilator devices may outweigh the potential risks identified in the recall notification. You can read the press release here. Note that this will do nothing for . 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. The DreamStation 2 CPAP Advanced is designed to provide a simplified user experience, including a premium color touchscreen with fewer panes to navigate. Based on the comprehensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. Can I buy one and install it instead of returning my device? Disclaimers * Voluntary recall notification in the US/field safety notice for the rest of the world. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPap (Bi-Level Positive Airway Pressure) sleep apnea devices. You must register your recalled device to get a new replacement device. The following products listed are affected by the recall notification / field safety notice: Continuous Ventilator, Minimum Ventilatory Support, Facility Use, Also known as BiPAP Hybrid A30Ventilator (A-Series), Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). It may also lead to more foam or chemicals entering the air tubing of the device. *. Repair and Replacement Be sure to place your mask, tubing and SD card aside as they may be used with your replacement device. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. If you do not find your device on the list of recalled models or during registration: You may want to contact the medical equipment supplier (commonly known as a Durable Medical Equipment (DME) supplier) who gave you your device. The FDA recommended, and Philips has agreed, to implement a prioritization approach that ensures patients who are most vulnerable to poor health care outcomes with continued use or ceasing use of the Recalled Products receive replacement devices as quickly as possible. 1-800-229-6417 option 1. This means you can set the Ramp Plus presusre once and there is no need to restart it each night. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. The DME supplier can check to see if your device has been recalled. Entering your device's serial number during registration will tell you if it is one of the recalled models . On May 24, Philips Respironics issued a press release that provides updated information on our comprehensive testing and research program. For patients using life-sustaining mechanical ventilator devices, they should not stop or change ventilator use until they have talked to their health care providers regarding factors including: Whether in the judgement of the treating clinical team the benefit of continued usage of these ventilator devices may outweigh the potential risks identified in the recall notification. Doing this could affect the prescribed therapy and may void the warranty. How to check for recalls using DoNotPay's Product Recall Monitor: If you don't have a specific recalled product in mind yet, DoNotPay can check to see if any of your recent purchases have been recalled. Yes, Philips has recalled some of its ventilators, CPAP and BiPAP machines. They are encouraging everyone to register their device with Philips Respironics on their website or call 877-907-7508. Alongside this, we have expanded our pool of experts in the areas of treatment and components, including specialists in toxicology, biocompatability and chemistry. Sleep apnea is a medical condition that affects an estimated 22 million Americans. Koninklijke Philips N.V., 2004 - 2023. Frequently updating everyone on what they need to know and do, including updates on our improved processes. The potential issue is with the foam in the device that is used to reduce sound and vibration. In addition, we are beginning the rework of affected Trilogy 100/200 devices at Philips Service Centers and designated remanufacturing sites in many markets. Purchase an in-line antibacterial filter (search for "antibacterial filter for cpap" on Amazon or another site) to catch any and all foam particles. CPAP machines deliver a continual stream of filtered and pressurized air into a patient's airway to hold the. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. * Voluntary recall notification in the US/field safety notice for the rest of the world. If you have a DME and have not already, please contact notify them that they need to register your affected device serial number so that we can match you to your DME and continue the process. I have seen foam repair kits offered online at Amazon.com and elsewhere from third parties. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance Healthcare providers, patients, and other stakeholders should use the complete update, including information on the limitations of the testing, for any informed decision making and should not solely rely on the overview presented here. We have developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue and have already begun this process. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Philips CPAP Recall Status Following the initial recall of Philips CPAP, BIPAP and ventilator machines in June 2021, predominantly from the DreamStation line of products, an additional recall was issued in October 2022. If you have been using a CPAP or medical device included in the recall, you should: Locate your serial number. The potential issue is with the foam in the device that is used to reduce sound and vibration. SarcasticDave94. In most markets, devices currently authorized for repair and replacement include DreamStation CPAP and Bi-level devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). We appreciate your cooperation and patience and encourage you to save your registration confirmation number for future communications. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. We understand that any change to your therapy device can feel significant. Based on our analysis, the root cause of this issue is related to the sound abatement foam, currently used to reduce noise and vibration in specific identified products of the Sleep & Respiratory Care portfolio. They do not include user serviceable parts. More information on the recall can be found via the links below. If you have received your replacement device and need assistance to set it up, visit the Philips website for support. More information and instructions on how to register for preservation may be found at: https://www.mdl3014preservationregistry.com . During the recertification process for replacement devices, we do not change the device serial number or model number. They are not approved for use by the FDA. Are there any recall updates regarding patient safety? Jeffrey Reed, who experienced persistent sinus infections and two bouts of pneumonia while using a Philips CPAP machine, poses . You do not need to register your replacement device. Although you may feel anxious at the news of the recall, we encourage you to talk to your doctor about the right treatment for you. You can view: safety recalls that have not been checked or fixed. Locate that and on that label, there will be a series of numbers that follow a SN or S/N pattern. This replacement reinstates the two-year warranty. On June 3, 2019, I ordered a So Clean machine for cleaning my CPAP (Invoice # *****) and paid $458.85 on my credit card. 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. If you are used to using a DreamStation CPAP device and have received a new DreamStation 2 CPAP Adanced, this new device has also been set to the same prescription settings as before and is ready for use. Patients who have already registered their recalled machine with Philips can check the status of their recall at the Philips Recall Portal; Additional Actions. While recalled devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and remediated devices is a silicone foam*. You can find the list of products that are not affected here. "The object in life is not to be on the side of the majority, but to escape finding oneself in the ranks of the insane." -- Marcus Aurelius. Recall Status 1: Open 3, Classified: Recall Number: Z-1974-2021: Recall Event ID: 88058: 510(K)Number: K122769 K131882 K131982 K130077 K091319 K113068 . CPAP Machines & Masks, and Oxygen Concentrators - Services From . Based on the comprehensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. Patients, physicians and durable medical equipment (DME) suppliers can call Philips at 877-907-7508 for additional support. 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. The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). The FDA classified the June 2021 Philips recall of certain ventilators, BIPAP machines, and CPAP machines as a Class I recall, the most serious type of recall. We know the profound impact this recall has had on our patients, business customers, and clinicians. Please continue to follow the recall / field safety notice instructions you have received for affected Philips Respironics Sleep & Respiratory Care devices. In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). Medical Device Recall Information 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).