Problems 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.