The FDA announced today that it has received more than 90,000 reports of problems — including 260 mentioning deaths — in Philips’ massive respiratory devices recall. It’s important to note that FDA’s Medical Device Reporting (MDR) system is a passive system with limitations. Still, today’s update from the FDA is but another reminder of the […]
Philips Respironics
New Philips CEO says he is ‘deeply sorry’ over Respironics recall
Royal Philips’ new CEO Roy Jakobs has apologized for the company’s ongoing massive Respironics recalls. Since April 2021, the FDA has received more than 69,000 medical device reports, including 168 reports of death, related to sound abatement foam breaking down in CPAP and BiPAP ventilators and other respiratory devices. (Note: The FDA’s MDR system is […]
Philips Respironics CPAP, BiPAP mask recall is Class I
The FDA today issued a notice confirming that a recall of Philips (NYSE:PHG) Respironics face masks is Class I, the most serious kind. Last month, Philips provided an update on an issue with its CPAP and BiPap masks. The Respironics subsidiary alerted users of CPAP or BiPAP therapy masks with magnetic headgear clips or straps. […]
Another Philips respiratory devices recall receives a Class I label
The FDA announced today that it is labeling another Philips Respironics recall as Class I, its most serious classification. The new recall involves 386 ventilators distributed from Aug. 6, 2020, to Sept. 1, 2021. The BiPAP machines may contain plastic in their motors that could release volatile organic compounds (VOCs). On top of the risk […]
Philips Respironics issues warning for magnets on CPAP, BiPAP masks
Philips (NYSE:PHG) is warning users of certain therapy masks about potential issues with implanted devices. The company’s Respironics subsidiary alerted users of CPAP or BiPAP therapy masks with magnetic headgear clips or straps that could negatively interact with implantable, metallic medical devices. Respironics has distributed more than 17 million masks containing magnetic clips. As of […]
Philips Respironics has a new recall for certain ventilators
Philips (NYSE:PHG) has a new recall for its ventilators, adding to recall issues that have plagued the company for a year. The FDA issued a notice alerting patients, caregivers and providers that certain Philips Respironics bi-level positive airway pressure (BiPAP or BPAP) machines may contain a plastic contaminated with a non-compatible material. If such plastic […]
FDA says 44 more deaths have been reported in Philips ventilator recall
The FDA has received reports of 44 more deaths associated with Philips Respironics’ massive respiratory device recall. FDA’s update, posted yesterday, brings the death total to 168, with 69,000 medical device reports (MDRs) filed related to the recall. The news comes amid Philips’ announcement that CEO Frans van Houten and the company’s supervisory board agreed […]
Philips updates on testing results for recalled ventilators
Royal Philips (NYSE:PHG) says only a small portion of returned respiratory devices displayed the sound abatement foam degradation that sparked a massive recall. Repeated ozone cleaning may have made the problem worse. Those were some of the major takeaways from an update Philips provided today on a comprehensive test and research program it implemented after […]
FDA says Philips ventilator recall produced over 21,000 device reports, 124 deaths
The FDA updated its communications on Philips‘ (NYSE:PHG) major ventilator recall with new data on device reports and patient deaths. In June 2021, Philips Respironics recalled millions of certain ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam […]
FDA may order Philips to resolve respiratory devices recall
The FDA has proposed an order requiring Philips (NYSE:PHG) to submit a plan for its recalled respiratory devices. FDA’s proposal regards the June 2021 recall of millions of certain Philips ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement […]
DOJ subpoenas Philips over Respironics recall; CEO addresses investigation
Royal Philips (NYSE:PHG) today disclosed a Department of Justice subpoena for information related to the massive recall of Respironics respiratory devices. Philips Respironics and Philips subsidiaries in the U.S. received the subpoena on April 8 seeking “information related to events leading to the Respironics recall,” the Amsterdam-based company said as it announced its latest financial […]
