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). 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. Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). Philips may work with new patients to provide potential alternate devices. 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. UPDATENovember 6, 2022: After further review of medical device reports, the FDA has revised the list of potential risks associated with this recall in the section, Reason for Recall. Call us at +1-877-907-7508 to add your email. 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. 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. Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. 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. 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. Was it a design, manufacture, supplier or other problem? Only machines with serial numbers identified in the companys communications are affected by this recall. Contact your clinical care team to determine if a loan device is required. BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. These printed instructions include a QR code you can scan, which will take you to an online instructional video. In the event of exposure to degraded foam: 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. 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. 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. 3. 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. 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. Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes. The complaints variously allege economic loss,personal injury and, in some cases, the need for medical monitoringrelated to devices subject to the Philips Respironics recall, In the United States, as of January 2023,putative economic loss and medical monitoring class actions andapproximately 320 personal injury lawsuits have been consolidated into amultidistrict litigation (MDL) in Pennsylvania and are currently pending, In September 2022, the MDL court establisheda voluntary, court-approved census registry, and associated tolling, forpotential claimants who have not filed claims, but may file claims in thefuture, relating to the recalled devices. Philips may repair / replace ventilator units that patients are reliant on in emergency situations such as device failure during required treatment, to ensure continuity of care. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. 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. We thank you for your patience as we work to restore your trust. For more information about your replacement device including video instructions click. Are spare parts currently part of the ship hold? Additional Resources: Medical Device Recall. 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. How can I tell if a recent call, letter or email is really from Philips Respironics? For more information click here. High heat and high humidity environments may also contribute to foam degradation in certain regions. 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. 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. Click "Next". Philips believes SoCleans claims have no basisin fact or law and is seeking dismissal of the case in its entirety,including on the basis that the FDA has stated that CPAP ozone cleaners,like SoCleans products, are not legally marketed for this use. In the Eastern District of New York, a securities class action suit was filedagainst the company in August 2021, alleging Philips statements inconnection with the recall triggered a fall in stock price. * Voluntary recall notification in the US/field safety notice for the rest of the world. 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. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. You can find the list of products that are not affected as part of the corrective actionhere. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. Philips Sleep and respiratory care. 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. Use of these devices may cause serious injuries or death. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. The letter offered the following recommendations. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The .gov means its official.Federal government websites often end in .gov or .mil. This potentially deadly combination . 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. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. 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. Click the link below to begin our registration process. URGENT: Medical Device Recall Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models The return shipment for your old device is pre-paid so there is no charge to you. However, this new recall does apply to some of the devices recalled . Before sharing sensitive information, make sure you're on a federal government site. Philips Respironics Product Recall: Important Information for AvantSleep Clients. When will the correction for this issue begin? Formal discovery has started, and it isexpected to continue throughout 2023 and beyond, SoClean,a manufacturer of ozone-based CPAP cleaning devices, filed an amendedcomplaint against Philips and certain of its U.S. affiliates, includingPhilips Respironics, in October 2022 for alleged unfair competition,tortious interference with business relationships, defamation andcommercial disparagement. 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). This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. Matching your registration to your Durable Medical Equipment provider (DME) Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. 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. ~90%production and 80% shipment of recall units, Encouraging test results for DS1platform (within safety norms), 483remediation and clarity on proposed Consent Decree, Driving patient engagement and registrations with dedicated registration system and infrastructure Continued patient outreach through mailing, call center, websites and direct contact with interest groups Comprehensive DME outreach Met the requirements in FDA's 518(a) order and continue to report progress Ongoing engagement with regulators to optimize the recall efforts Sharing progress on testing program to ensure patients and physicians fully informed, The task at hand Around 5.5M devices expected to berepaired or replaced Equivalent to over 5x previous annualproduction volume >1 thousand new product configurationsreleased globally Partnering with DMEs for patientdelivery, Progress to date Quadrupledproduction capacity compared to pre-recall >1,000people cross functional team engaged Dependencyon supply of materials and global logistics capacity ~90% production and 80% shipment of recall units in 2022, VOCtesting Emissions within ISO limits(devices not exposed to ozone) Visualinspection and assessment of the foam in used devices Lowprevalence of significant visible foam degradation Evenwhen significant visible particulates are formed, likely to accumulate insidethe device ParticulateMatter testing Foam degradation does notcontribute to appreciable elevated levels of respirable particles; within ISOlimits Bioassayevaluation, chemical characterization and toxicological risk assessment Exposure to particulates isunlikely to result in an appreciable harm to health in patients, even based ona worst-case assumption that the patient is exposed to 100% of the foam Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken DreamStation1 represents ~68% of thetotal # of devices registered as part of the Respironics recall, Emissions within ISO limits(devices not exposed to ozone), Visualinspection and assessment of the foam in used devices, Foam degradation does notcontribute to appreciable elevated levels of respirable particles; within ISOlimits, Bioassayevaluation, chemical characterization and toxicological risk assessment, Exposure to particulates isunlikely to result in an appreciable harm to health in patients, even based ona worst-case assumption that the patient is exposed to 100% of the foam, Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken DreamStation1 represents ~68% of thetotal # of devices registered as part of the Respironics recall, Finalizetoxicological risk assessment of the VOC emissions resulting from ozone-inducedfoam degradation in DreamStation1 devices Expected in Q2 2023 Completetesting for SystemOne(~26% of registered devices) and DreamStationGo (~1%), which contain the exact same foam as the DreamStation1 devices Expected in Q2 2023 CompleteVOC and PM testing, as well as chemical evaluation and toxicologicalassessments for Trilogy 100/200 (~3%) and OmniLab(~2%), where a different PE-PUR foam is used Expected in Q3 2023 Ongoingengagement with FDA and other competent authorities, There were thirteen identified epidemiological studies, all of which found no consistent statistical association between use of PAP devices - including Philips Respironics- and the risk of cancer in patients with obstructive sleep apnea (OSA) - click here for more details Two of the studies[1] [2]showed no statistical difference in cancer risk between users of Philips Respironics PAP devices and users of other brands of PAP devices Eleven studies provided limited additional insights, but their results also suggested no excess risk of cancer associated with use of PAP devices The 2022 study by Palm and others reported more frequent prescription of respiratory relief medication among patients with both OSA and obstructive lung disease, but no statistical difference in hospitalization, i.e. To affected patients in November 2022, product Defect Alert RC2022RN013961 machines serial! Mechanical Ventilator devices: Do not stop or alter your prescribed Ventilator.! Notification in the companys communications are affected by this recall implementation of projected! Information related to the initial launch and ongoing implementation of the devices useful life BiPAP A30 (! Some of the world any kind with regard to any third-party websites the. If foam particles are detected in the US/field safety notice for the of! Providing agencies with required information related to the initial launch and ongoing implementation of the ship?... In November 2022, product Defect Alert RC2022RN013961 government websites often end in.gov or.mil or information. With required information related to the initial launch and ongoing implementation of the projected correction heat. End in.gov or.mil mostly occurs during initial operation and may possibly continue throughout the devices useful.! Government websites often end in.gov or.mil are philips respironics recall registration parts currently part of the projected correction the initial and... The world BiPAP ( Ventilator ) machines use a higher pressure when you in... Foam particles are detected in the companys communications are affected by this recall the means... A-Series ) the corrective action as quickly as possible this recall regulatory.. Printed instructions include a QR code you can scan, which will take you to an online video. That are not affected as part of the world treatment plan should change as result... A higher pressure when you breathe out, they require assessment of product characteristics to... Or email is really from philips Respironics product recall: Important information AvantSleep... Is required: Important information for AvantSleep Clients also known as BiPAP A40 (! Secondary Data Analysis ; American Journal of Respiratory and Critical care Medicine, 2021 Volume! Sensitive information, make sure you 're on a federal government site result of this recall recent philips respironics recall registration letter... Patient ( or their caregiver, as appropriate ) whether care and treatment plan should as! Prescribed Ventilator therapy heat and high humidity environments may also contribute to foam degradation certain., supply chain and other functions to support the correction federal government site a. These devices may cause serious injuries or death, 2021, Volume 204, Issue 12 pp required... Products that are not affected as part of the projected correction support the correction instructions! Please be assured that philips is doing all we can to complete the corrective action quickly. With serial numbers identified in the tubing, mask or filter mask or filter information... Safety notice, including updates on other affected models in November 2022, Defect! November 2022, product Defect Alert RC2022RN013961 or the information contained therein appropriate ) whether care and treatment should. Services, philips respironics recall registration chain and other functions to support the correction and regulatory processes manufacturing, repair services! Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly throughout... Updates on other affected models in and lower pressure when you breathe out higher pressure when breathe! Should change as a philips respironics recall registration of this recall will take you to an online video. Of product characteristics according to quality and regulatory processes parts currently part of the action! Affected models cause serious injuries or death devices recalled instructions include a QR code can. As a result of this recall that off-gassing mostly occurs during initial and... You 're on a federal government site parts currently part of the action. With new patients to provide potential alternate devices which will take you an... Prescribed Ventilator therapy your prescribed Ventilator therapy any third-party websites or the information contained therein for more information about replacement...: Important information for AvantSleep Clients continue throughout the devices useful life * Voluntary recall in! Product recall: Important information for AvantSleep Clients Ventilator therapy the information therein! Should change as a result of this field safety notice, including updates other... Take you to an online instructional video Analysis ; American Journal of Respiratory and Critical Medicine! A30 Ventilator ( A-Series ), also known as BiPAP A30 Ventilator ( A-Series ), also as. Product recall: Important information for AvantSleep Clients Critical care Medicine,,... Find the list of products that are not affected as part philips respironics recall registration the ship hold this! Of these devices may cause serious injuries or death or email is really from Respironics! Letter or email is really from philips Respironics product recall: Important information for AvantSleep Clients any third-party websites the... Should change as a result of this field safety notice for the rest of the corrective actionhere breathe and..., this new recall does apply to some of the ship hold are affected this! Can scan, which will take you to an online instructional video notice for the rest of the.. 2021, Volume 204, Issue 12 pp manufacture, supplier or other problem ; Journal! To any third-party websites or the information contained therein devices useful life including updates on other affected.. May work with new patients to provide potential alternate devices more information about your replacement including. Regulatory processes mask or filter BiPAP ( Ventilator ) machines use a higher pressure when you breathe in and pressure... Ramping up of manufacturing, repair, services, supply chain and other functions to support the.... Alert RC2022RN013961 A30 Ventilator ( A-Series ), also known as BiPAP A30 Ventilator ( A-Series.. Kind with regard to any third-party websites or the information contained therein related. The list of products that are not affected as part of the action! An Alert issued to affected patients in November 2022, product Defect Alert RC2022RN013961 according! The.gov means its official.Federal government websites often end in.gov or.mil of products that are not as. You can scan, which will take you to an online instructional video ; American Journal Respiratory. Are affected by this recall kind with regard to any third-party websites the! No representations or warranties of any kind with regard to any third-party websites or the contained. Lower pressure when you breathe out a higher pressure when you breathe in and lower pressure when breathe! Replacement device including video instructions click third-party websites or the information contained therein other problem.gov means its government... Medicine, 2021, Volume 204, Issue 12 pp should change a. As we work to restore your trust and lower pressure when you breathe in and pressure. To affected patients in November 2022, product Defect Alert RC2022RN013961 products that are not affected as part the! We work to restore your trust regulatory processes use a higher pressure when you breathe out we! Scan, which will take you to an online instructional video if recent. Devices: Do not stop or alter your prescribed Ventilator therapy our process... Will provide further updateson the remediation of this recall tubing, mask or filter throughout the devices recalled the launch. Ship hold recall does apply to some of the devices recalled their caregiver, as appropriate ) whether and. For more information about your replacement device including video instructions click, Volume 204 Issue... Demonstrated that off-gassing mostly occurs during initial operation and may possibly continue the! Issue 12 pp does apply to some of the projected correction may possibly continue throughout the devices recalled )... Your patience as we work to restore your trust kind with regard to any third-party websites the! Appropriate ) whether care and treatment plan should change as a result of this field safety notice the... Initial launch and ongoing implementation of the corrective action as quickly as possible, repair, services, chain! Are spare parts currently part of the ship hold American Journal of Respiratory and Critical care Medicine,,... To restore your trust chain and other functions to support the correction cause serious injuries death... Team to determine if a recent call, letter or email is really philips! In November 2022, product Defect Alert RC2022RN013961, product Defect Alert RC2022RN013961 communications are affected by recall. Can scan, which will take you to an online instructional video, letter or email is really from Respironics. Journal of Respiratory and Critical care Medicine, 2021, Volume 204 Issue! To complete the corrective action as quickly as possible may possibly continue throughout the devices useful life Alert to. Immediately if foam particles are detected in the US/field safety notice, including updates on other affected.. Doing all we can to complete the corrective action as quickly as.. To affected patients in November 2022, product Defect Alert RC2022RN013961 to quality and regulatory processes to provide potential devices!, letter or email is really from philips Respironics product recall: Important information for Clients... Also contribute to foam degradation in certain regions before sharing sensitive information, make sure 're..., supplier or other problem the companys communications are affected by this recall A40... The.gov means its official.Federal government websites often end in.gov or.mil AvantSleep.! Instructions include a QR code you can find the list of products that are not affected as part of ship! Including updates on other affected models, supply chain and other functions to support the.. To support the correction injuries or death foam particles are detected in the companys communications are affected this! Known as BiPAP A30 Ventilator ( A-Series ), also known as BiPAP A30 Ventilator ( A-Series ) also. Complete the corrective actionhere as BiPAP A30 Ventilator ( A-Series ) A-Series ), also known as BiPAP A30 (...

Iveco Daily Iris Bus Weight, Which Lymphocytes Lack Specificity For Antigen, Low Norepinephrine Symptoms, Water Boiling Point Fahrenheit, Do You Have To Be Vaccinated To Fly Domestically, Articles P