If your physician determines that you must continue using this device, use an inline bacterial filter. Particles or other visible issues? How can I tell if a recent call, letter or email is really from Philips Respironics? The company will replace the current sound abatement foam with a new material that is not affected by this issue, and has already begun this process. We also remind customers and patients to review the age of their BiLevel PAP and CPAP devices, Philips recommends that devices are replaced after five years of use. Therecall notification (U.S. only) / field safety notice (International Markets) provides customers with information on how to identify affected products. 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. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. If you do not have this letter, please call the number below. You can access the Philips RS North America webpage by clicking here. The following updates in relation to device testing have been released by Philips RS North America on this webpage: Please note that the Philips RS North America website also contains information specific to the CPAP, BiPAP and mechanical ventilator device recall in the USA, which may be different to and not relevant for Australia. 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. What devices are affected by the recall notification (U.S. only) / field safety notice (International Markets)? Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. At this time, Philips is unable to set up new patients on affected devices. 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. 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 to Register Your Device: Go to the Philips Respironics Recall Registration Link: Click Here. kidneys and liver) and toxic carcinogenic affects. Have regulatory authorities classified the severity of the recall? The device types are: DreamStation CPAP, Auto CPAP and Auto BiPAP DreamStation ASV DreamStation AVAPS System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series) System One ASV4 (50 and 60 Series) C Series S/T and AVAPS A-SeriesBiPAP (A40 and A30) For patients who registered their DreamStation Go, Philips Australia commenced the replacement program for DreamStation Go devices in December 2022 and it will continue into Q1 2023. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). How will Philips address this issue? For more information click here. 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. 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. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks. In June 2021, after discovering apotential health risk related to a part in certain CPAP, BiPAP and MechanicalVentilator devices, Philips issued a voluntary Field Safety Notice (Internationalmarkets) / voluntary recall notification (U.S. only). 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. Are you still taking new orders for affected products? The following products listed are affected by the correction: Continuous Ventilator, Minimum Ventilatory Support, Facility Use, Information for Trilogy 100 patients with a repaired device. 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. 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 (International markets) / voluntary recall notification (U.S. only). Are spare parts currently part of the ship hold? After registration, we will notify you with additonal information as it becomes available. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. What happens after I register my device, and what do I do with my old device? However, this new recall does apply to some of the devices recalled . Click the link below to begin our registration process. On Friday July 2 2021, following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, Philips Australia and New Zealand announced it is conducting an Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand for the specific affected devices. See all support information What devices have you already begun to repair/replace? You are about to visit the Philips USA website. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. 2. Philips has determined that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone), and certain environmental conditions involving high humidity and temperature. 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. For more information click here. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. Are affected devices being replaced and/or repaired? [2] Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea, European Respiratory Journal 2022, in press (https://doi.org/10.1183/13993003.00551-2022), Grgoire Justeau, Chlo Gervs-Pinqui, Marie Jouvenot, Thierry Pigeanne, Sandrine Launois, Laurene Leclair-Visonneau, Philippe Masson, Acya Bizieux-Thaminy, Sbastien Bailly, Nicole Meslier, Abdelkebir Sabil, Jean-Louis Racineux, Wojciech Trzepizur, and Frdric Gagnadoux. 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. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. 1. This recall notification / field safety notice has not yet been classified by regulatory agencies. There is nothing we take more seriously than providing patients with highquality products that are safe and reliable. 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. Talk with health care providers to decide if your care and treatment should change as a result of this recall. The company has dedicated significant resources to address this issue, and has developed a comprehensive plan for this correction, and has already begun this process. Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand). 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. Phillips sent affected customers an Urgent Medical Device Recall letter on August 26, 2022. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? 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. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. Has Philips received any reports of patient harm due to this issue? If you use one of the affected devices, the Medical Device recall notification (U.S. only) / field safety notice (International Markets) advises patients and customers to take the following actions: Continue life-sustaining ventilation prescribed therapy, Stop use of BiLevel PAP & CPAP sleep apnea devices, View affected BiLevel PAP and CPAP sleep apnea devices, Philips CEO Frans van Houten and Chief Business Leader Connected Care Roy Jakobs talk about the various aspects of the field safety notice, Technical Project Manager Jan Bennik speaks about the test and research program, Durable Medical Equipment Providers, Distributors, or Medical Institutions, Template web copy block for DME and HCP use, Physician engagement letter for DME and HCP use. For Spanish translation, press 2; Para espaol, oprima 2. . 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. We are investigating potential injury risks to users, including several cancers. 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. 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. Replace these devices with an unaffected device. 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. The FDA has identified this as a Class I recall, the most serious type of recall. Always ensure you are being taken care of, i.e. Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Once you receive your replacement device, you will need to return your old device. To register by phone or for help with registration, call Philips at 877-907-7508. An official website of the United States government, : Philips CPAPs cannot be replaced during ship hold. 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. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. The criminal and civil investigation is being conducted by the DOJs Consumer Protection Branch and Civil Fraud Section and the US Attorneys Office for the Eastern District of Pennsylvania, Collectiveand individual civil complaints have been filed in various jurisdictionsglobally, including but not limited to the United States, Australia,Canada, Israel and Chile. For more information about your replacement device including video instructions click. Patient safety is our top priority, and we are committed to supporting ourpatients, durable medical equipment providers (DMEs), distributors, home healthpartners, and clinicians through the complete remediationprocess. This time, Philips is unable to set up new patients on affected devices on the recall device. Therecall notification ( U.S. only ) / field safety notice ( International Markets ) have regulatory authorities classified severity... 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