Editing Philips (section)

== Respironics recall ==
{{further|Respironics#Hazardous foam and product recall}}

In June 2021, Philips announced a voluntary recall of several of its Respironics ventilators, BiPAP, and CPAP machines due to potential health risks. Gradual degradation of foam in the devices, intended to reduce noise and vibrations during operation, could result in patients inhaling particulates or certain chemicals.<ref name="FDA-recall">{{cite web |title=UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication |url=https://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due |website=US Food & Drug Administration |access-date=30 January 2024}}</ref> The recall involved around 3 to 4 million machines which, in addition to the [[COVID-19 pandemic]], contributed to a supply chain crisis impeding the availability of these devices to patients.<ref>{{Cite journal |last1=Owens |first1=Robert L. |last2=Wilson |first2=Kevin C. |last3=Gurubhagavatula |first3=Indira |last4=Mehra |first4=Reena |date=15 October 2021 |title=Philips Respironics Recall of Positive Airway Pressure and Noninvasive Ventilation Devices: A Brief Statement to Inform Response Efforts and Identify Key Steps Forward |journal=American Journal of Respiratory and Critical Care Medicine |language=en |volume=204 |issue=8 |pages=887–890 |doi=10.1164/rccm.202107-1666ED |issn=1073-449X |pmc=8534631 |pmid=34461022}}</ref> Originally, Philips described the risks as potentially "life-threatening" but that there had been no reports of death as a result of the issues.<ref>{{cite web |last=Mell |first=Rodney |title=URGENT: Medical Device Recall - Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models |url=https://www.philips.com/c-dam/b2bhc/master/landing-pages/src/update/documents/philips-recall-letter-2021-05-a-2021-06-a.pdf |website=Philips |access-date=30 January 2024}}</ref> Since then, the [[FDA]] has received 385 reports of death allegedly caused by the foam issue.<ref name="FDA-recall" />

In 2023, [[ProPublica]] and the [[Pittsburgh Post-Gazette]] reported that Philips had received thousands of patient reports and returned machines affected by the degrading foam as far back as 2010, and many of these reports were not disclosed to the FDA as Philips was legally obligated to do.<ref name=":0">{{Cite web |last1=Cenziper |first1=Debbie |last2=Sallah |first2=Michael D. |last3=Korsh |first3=Michael |last4=Robinson-Johnson |first4=Evan |last5=Sager |first5=Monica |date=27 September 2023 |title=Philips Kept Complaints About Dangerous Breathing Machines Secret While Company Profits Soared |url=https://www.propublica.org/article/philips-kept-warnings-about-dangerous-cpaps-secret-profits-soared |access-date=6 November 2023 |website=ProPublica |language=en}}</ref>

In October 2022, dozens of lawsuits against Philips related to the safety concerns were consolidated into one class-action lawsuit. Philips settled this lawsuit in September 2023 for at least $479 million.<ref>{{cite news |last1=Brooks |first1=Khristopher |title=Philips Respironics agrees to $479 million CPAP settlement |url=https://www.cbsnews.com/news/philips-settlement-cpap-recall-lawsuit-fda/ |access-date=30 January 2024 |work=CBS News |date=8 September 2023}}</ref> In January 2024, Philips agreed to halt the sale of any new sleep apnea devices in the US as part of an agreement with the FDA. As part of the deal, Philips would need to meet certain conditions in its US manufacturing plants, a process that Philips CEO Roy Jakobs said could take five to seven years.<ref>{{cite news |last=Meijer |first=Bart H. |title=Philips' US sales of sleep apnea devices face years-long halt after FDA deal |url=https://www.reuters.com/business/healthcare-pharmaceuticals/philips-reaches-compliance-agreement-with-fda-over-ventilator-recall-2024-01-29/ |access-date=30 January 2024 |work=Reuters}}</ref>