Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use. In the event of exposure to degraded foam: In the event of exposure to chemical emissions: Philips is notifying regulatory agencies in the regions and countries where affected products are available. Always ensure you are being taken care of, i.e. At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible. CHEST Issues Joint Statement in Response to Philips Device Recall . Before sharing sensitive information, make sure you're on a federal government site. The potential risks of exposure due to chemical emissions from affected foam include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. The list ofaffected devices can be found here. The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. How to Register Your Device: Go to the Philips Respironics Recall Registration Link: Click Here. See all support information How are you removing the old foam safely? This Alert was related only to Trilogy 100 ventilators that were repaired. The potential risks of degraded foam exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. The recall notification(U.S. only) / field safety notice (International Markets) informs customers and users of potential impacts on patient health and clinical use related to this issue. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. Philips may work with new patients to provide potential alternate devices. The relevant subsidiaries are cooperating with the agency. You are about to visit the Philips USA website. No further products are affected by this issue. The recall notes that the foam may degrade over time and may also emit at least two harmful toxins. The FDA is not aware of any reports of serious injury or death associated with the recalled BiPAP machines due to the contaminated plastic issue. Only machines with serial numbers identified in the companys communications are affected by this recall. If you have not done so already, please click here to begin the device registration process. What devices have you already begun to repair/replace? The FDA also issued a safety communication, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue, for health care providers, patients and their caregivers. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. Create account Create an account You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. Are affected devices safe for use? 2. Philips Respironics relied on an initial, limited data set and toxicological risk assessment, and assumed a worst-case scenario for the possible health risks out of an abundance of caution. The potential risks associated with this recall include: If the plastic causes the machine to fail and stop working suddenly, it may also lead to serious injury or death. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Affected devices currently will be either replaced with a new or refurbished unit that incorporates the new material, or repaired to replace the sound abatement foam in customer units. Replace these devices with an unaffected device. Following feedback from caregivers, we would like to provide improved instructions on how to appropriately respond to alarms. Philips Sleep and Respiratory Care Devices - Australia and New Zealand Register your device On April 26, 2021, Philips globally provided an important update to the market regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio. Is this a recall? We thank you for your patience as we work to restore your trust. Following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, the Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand will advise patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: For patients using life-sustaining mechanical ventilator devices: The issue relates to certain ventilators, Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bi-Level Positive Airway Pressure) sleep apnoea devices. This information has not been separately verified by Philips Electronics Australia Ltd. 1800 009 579 in Australia or 0800 578 297 in New Zealand. To resolve this situation as quickly as we can, we are doing the following: Working to reach everyone affected by the corrective action so they understand the situation and know what they need to do, starting with the registration of the affected devices. Click here to view a Notice from the Federal Court of Australia advising Group Members of the proposed discontinuance of a class action commenced by Mr Peter Lewis, represented by Carbone Lawyers, against Philips in relation to certain CPAP, Bi-PAP and mechanical ventilators. Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). For more information on the recall notification (U.S. only) / field safety notice (International Markets), as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. Following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, the Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand will advise patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: Stopping treatment suddenly could have an immediate and detrimental effect on patient health. The website provides current information on the status of therecall notification (U.S. only) / field safety notice (International Markets) and how to receive permanent corrective action to address the two issues. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. For more information on the recall notification, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. 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. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. Philips Australia will work with your clinical care team to arrange a loan device, where required. We thank you for your patience as we work to restore your trust. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. This recall is for all CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. Philips Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. Contact your clinical care team to determine if a loan device is required. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. Doing this could affect the prescribed therapy. As a first step, if your device is affected, please start theregistration process here. URGENT: Medical Device Recall Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models What is the advice for patients and customers? Follow those instructions. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. Products not affected by thisrecall notification (U.S. only) / field safety notice (International Markets) include: Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Are there any steps that customers, patients, and/or users should take regarding this issue? Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. In the event of exposure to chemical emissions: The potential risks of exposure due to chemical emissions from affected foam include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Philips is notifying regulatory agencies in the regions and countries where affected products are available. Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods. Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods. Was it a design, manufacture, supplier or other problem? Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. Working to reach everyone affected by the corrective action so they understand the situation and know what they need to do, starting with the registration of the affected devices. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator). As a result of extensive ongoing review, on June 14, 2021, Philips voluntarily decided to issue a global recall notification related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. Philips continues to monitor reports of potential safety issues through our post-market surveillance activities as required by medical device regulations and laws in the markets in which we operate. All rights reserved. Testing is ongoing and you can obtain further information about the. Theremediation of this field safety notice is underway and has started for the following devices: Philips aims to address allaffected devices within the scope of this field safety notice but due to thevolume of devices that have been affected, we regret it may take some time torepair or replace patients' devices. 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. Patient safety is our top priority, and we are committed to supporting our . Will existing patient devices that fail be replaced? Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets), www.philips.com/SRC-update. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. The letter offered the following recommendations. We are in touch with relevant customers and patients. You can find the list of products that are not affected as part of the corrective actionhere. 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