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Home » Philips faces legal scrutiny in France over respiratory devices recall

Philips faces legal scrutiny in France over respiratory devices recall

September 8, 2022 By Chris Newmarker

PhilipsProblems continue to mount around the massive respiratory device recall at Royal Philips (NYSE:PHG).

Reuters reported today that French prosecutors have opened a preliminary investigation into the recall, citing a text message from a Paris public prosecutor’s office spokesperson.

In the U.S., the FDA and federal prosecutors are increasingly scrutinizing how Philips has handled the deadly recall, which involves more than a million CPAPs, ventilators and other respiratory devices. Philips has effectively been removed from the respiratory devices market for a year as it deals with the recall. Roy Jakobs, the company’s Connected Care chief businesses leader who has been in charge of the recall, is slated to become CEO next month.

Respiratory device problems stem from polyester-based polyurethane sound abatement foam that could break down. Foam particles could enter a device’s air pathway and cause a range of potential health problems and toxic, carcinogenic effects for the user. The FDA has called for Philips to submit a plan for device repair, replacement or refund.

The problems appear to be even worse than previously thought. Philips and the FDA warned this week that about 17 million CPAP and BiPAP masks with magnetic headgear clips or straps could negatively interact with implanted metallic medical devices. Philips has reported 14 serious injuries, including pacemaker failure, arrhythmia, seizures and irregular blood pressure related to the recalled masks, according to the FDA.

 

Filed Under: Featured, Legal News, News Well, Recalls, Regulatory/Compliance Tagged With: Philips

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at [email protected].

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