Therecall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks. Please refer to the most recent User Manualfor more detailed information about the device and operation, including cleaning and adjusting yourpatient settings. The contacts included Durable Medical Equipment (DME) suppliers. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. BiPAP machines may be used to treat adult and pediatric patients at home and in clinical environments, such as hospitals and sleep laboratories, depending on the instructions for use for the particular device model. Register your device on the Philips recall website or call 1-877-907-7508. For more information click here. Further information in relation to the global recall and devices has been made available by the device manufacturer, Philips RS North America LLC, a company based in the USA. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. The correction program is now in progress for the following devices: DreamStation CPAP, Auto CPAP and Auto BiPAP, System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series). Are affected devices continuing to be manufactured and/or shipped? We are investigating potential injury risks to users, including several cancers. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. Customers who need any further information or support should contact Philips Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. The issues prompting the corrective action relate to the polyester-based polyurethane (PE-PUR) foam that is used in affected devices to reduce sound and vibration. The new material will also replace the current sound abatement foam in future products. If you have not done so already, please click here to begin the device registration process. For more information about your replacement device including video instructions click. (, On June 14, 2021,Royal Philips subsidiary, Philips Respironics, initiated a voluntary recall notification, Repair and Replacement, Testing and Program Management, The Respironics recall remains highestpriority, Takingthe learnings of Respironics recall to raise Patient Safety and Quality to the highest standards across Philips, Extensive patient,clinicianand regulator engagement, ~90%production and 80% shipment ofrecall units in 2022, Encouraging test results forDreamStation1 devices, Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken, Please click here for the latest testing results and updates, Summary of third-partyepidemiological studies, showed no statistical difference in cancer risk between users of Philips Respironics PAP devices and users of other brands of PAP devices, [2] Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea, European Respiratory Journal 2022, in press (, Regulatory and legal update - Civil litigation, Frequently Asked Questions and key materials, Respironics field action - FAQ - January 30, 2023, Summary of a systematic literature review of PAP device use and cancer risk - July 25, 2022, Third party epidemiological studies - FAQ related to the Swedish Study by Palm et al. Products not affected by thisrecall notification (U.S. only) / field safety notice (International Markets) include: All oxygen concentrators, respiratory drug delivery products, airway clearance products. Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . How will Philips address this issue? Philips recognises that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. Use of these devices may cause serious injuries or death. All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers. This recall is not associated with the PE-PUR foam issue impacting certain BiPAP machines recalled in June 2021, described in the Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. Is there any possibility others are affected? 1. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. This information has not been separately verified by Philips Electronics Australia Ltd. 1800 009 579 in Australia or 0800 578 297 in New Zealand. . The affected products are identified in the tables below: A-Series BiPAP A40 (not marketed in the US), A-Series BiPAP A30 (not marketed in the US), Products that are not affected by the corrective action may have different sound abatement foam material, as new materials and technologies have become available over time. Only machines with serial numbers identified in the companys communications are affected by this recall. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. This impacts all Philips Respironics CPAP and BiLevel PAP devices sold worldwide prior to April 26, 2021. Don't have one? You are about to visit a Philips global content page. Additional Resources: Medical Device Recall. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. All rights reserved. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. 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, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. If an issue arises, we areproactive in communicating and addressing it as we work tirelesslytowards a resolution. As a first step, if your device is affected, please start theregistration process here. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. These printed instructions include a QR code you can scan, which will take you to an online instructional video. 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. Philips has completed our analysis in accordance with our Quality Management System and identified all affected products, which are included in our notifications to regulatory agencies and customers. (0044) 20 8089 3822 Physicians and other medical care providers The environmental conditions that may be one of the causes of this issue refer to the climate and regional temperatures of the countries where the devices are used and stored. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. The company has developed a comprehensive plan for this correction, and has already begun this process. Philips Sleep and respiratory care. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. Philips Respironics has also been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks related to possible emission of particulates from degraded foam and certain Volatile Organic Compounds (VOCs). How long will it take to address all affected devices? Therecall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: 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. Koninklijke Philips N.V., 2004 - 2023. These devices are prescribed for people with obstructive sleep apnea syndrome to keep their airways open during sleep, for those who have respiratory insufficiency (not enough oxygen breathed in or carbon dioxide breathed out), or respiratory failure (stop breathing). Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. Product registration | Philips Product registration To register a new purchase, please have the product on hand and log into your My Philips account. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. Philips Australia expects to have completed the replacement program by the end of 2022 for the majority of devices where, by 12 December 2022, patients (1) registered a device type listed below; and (2) provided their device settings preference to Philips. Once you receive your replacement device, you will need to return your old device. After registration, we will notify you with additonal information as it becomes available. 4. Phillips sent affected customers an Urgent Medical Device Recall letter on August 26, 2022. BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. If you do not have this letter, please call the number below. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator) are used in clinical environment and home care settings, If the device was not already corrected or replaced through the June 2021 recall. What is the cause of this issue? This Alert was related only to Trilogy 100 ventilators that were repaired. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. 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. Additionally, the device Instructions for Use provide product identification information to assist with this activity. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. Begin registration process 877-907-7508 News and Updates > Important update to Philips US recall notification Important update to Philips US recall notification November 16, 2021 Philips has updated the US recall notification to align with the FDA's recommendation in connection with these recalls and provide broader guidance on use. When you receive your replacement device, in the box you will find instructions on how to set up your replacement device and return your old device. Please read the Notice carefully. 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. At this time, Philips is unable to set up new patients on affected devices. Have regulatory authorities classified the severity of the recall? Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. The products were designed according to, and in compliance with, appropriate standards upon release. Click the link below to begin our registration process. A bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machine pumps air under varying pressure into the airway of the lungs. You are about to visit the Philips USA website. Please note that some people will also receive a copy of the Notice by email or post. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. How are you removing the old foam safely? Disclaimers * This is a recall notification for the US only, and a field safety notice for the rest of the world, * This is a recall notification for the US only, and a field safety notice for the rest of the world. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. All patients who register their details will be provided with regular updates. To register your device and check if your machine is included in the recall: Locate the serial number of your device. Talk with health care providers to decide if your care and treatment should change as a result of this recall. 2. Create account Create an account Thecompany anticipates that the number of individuals on the census registrywill increase in 2023 In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. All rights reserved. Following Philips public statements on possible risks to users in April 2021 and the June 2021 recall notification/field safety notice, Philips Respironics received a steep increase in complaints allegedly associated with possible foam degradation. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The relevant subsidiaries are cooperating with the agency. 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. Patients who are concerned should check to see if their device is affected by the corrective action. 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. This includes Dreamstation, Dreamstation Go, Dreamstation ASV/ST/AVAPS, System One, and Remstar SE Auto CPAP unit. 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. For more information click here. Register your device (s) on Philips Respironics' recall website to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the. Register your product and enjoy the benefits. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. The return shipment for your old device is pre-paid so there is no charge to you. The foam degradation and chemical emission issues were discovered as part of our Quality Management System processes, and are being corrected in accordance with appropriate regulatory requirements. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. This could affect the prescribed therapy. 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. People who receive breathing support from the affected Philips BiPAP (ventilator) machines. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 4. Will existing patient devices that fail be replaced? At the bottom of this website, click Patient/Device User . 2. No further products are affected by this issue. Patient safety is our top priority, and we are committed to supporting our patients, durable medical equipment providers (DMEs), distributors, home health partners, and clinicians through the complete correction process. Philips Australia will work with your clinical care team to arrange a loan device, where required. Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. Click "Next". The list ofaffected devices can be found here. Theremediation of this field safety notice is underway and has started for the following devices: DreamStationCPAPs DreamStationBiPAPs DreamStationST/AVAPS 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. What is meant by "high heat and humidity" being one of the causes of this issue? Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Philips may work with new patients to provide potential alternate devices. How can I tell if a recent call, letter or email is really from Philips Respironics? Please note that the information available at these links has not been separately verified by Philips Australia. Before you send back your old device to Philips, please make sure that you remove and keep your current accessories (including your carry bag, mask, tubing, humidifier, battery, modem and SD card if applicable) as they may be used with your replacement device. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click here for more details. For further information please contact Philips on 1800 830 517 in Australia (toll-free) or +61 2 9151 0289 in New Zealand selecting option 1. You can find the list of products that are not affected as part of the corrective actionhere. Philips is notifying customers and users of affected devices that the company will replace the current sound abatement foam with a new material that is not affected by this issue. 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