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 […]
Philips Respironics
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 […]
Philips shares take a dive as supply chain issues, ventilator recalls impact Q1 results
Royal Philips (NYSE:PHG) shares took a hit today on first-quarter results that felt the effects of ongoing issues with supply chain and recalls. PHG shares were down 12.1% at $26.67 in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was virtually even on the […]
Philips has another round of serious ventilator recalls
Royal Philips’ (NYSE:PHG) ventilator problems continue as the company has issued further recalls for its respiratory devices. FDA earlier this week said it was designating more Philips recalls as Class I — the most serious kind. The recalls involve all models of the Philips Respironics V60 ventilator, the V60 Plus ventilator and the V680 ventilator […]
FDA orders Philips Respironics to improve communications over ventilator recall
The FDA issued a notification order alerting Philips (NYSE:PHG) that its notification efforts on the recall of its ventilators have been inadequate to date. Philips Respironics last year recalled millions of specific ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines due to polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. […]
FDA says Philips knew about toxic foam for years before massive recall
The FDA said it observed potential violations of federal medical device safety rules when inspecting a Philips Respironics manufacturing facility connected to the Class I recall of more than 15 million respiratory devices. The FDA recently requested additional safety testing on replacement materials and issued a Form 483. The form details how Philips and its foam supplier were aware […]
FDA requests safety testing of replacement foam in Philips sleep devices recall
The FDA said it has requested additional safety testing on the material used to repair Royal Philips (NYSE:PHG) sleep therapy devices recalled for foam that could harm patients using them. The Class I recall that started in June covers more than 15 million devices, after hundreds of complaints and more than 100 injuries from polyester-based […]
