Philips Respironics has recalled more than 5 million devices since 2021 due to dangerous degradation of sound abatement foam. The FDA has received more than 100,000 reports of problems related to the recall, including at least 385 linked to deaths.
While the company continues to work through its remediation process, more light has been shed on how the recall unfolded as it did. ProPublica and the Pittsburgh Post-Gazette first reported that Philips withheld its CPAP issues from the FDA for years. The reporting later revealed CEO Roy Jakobs’ apparent knowledge of the ongoing issues and alleged approval of the sale of defective devices.
The latest report from the news outlets says tests by independent laboratories found a different foam used in replacement machines also emitted formaldehyde and other dangerous chemicals. While Philips said the machines are safe, the outlets obtained test results showing how scientists working for the Dutch medtech giant “grew increasingly alarmed,” ProPublica and the Post-Gazette reported.
Philips’ new silicone foam, which features in the DreamStation 2 CPAP device, reportedly caught the eye of regulators more than two years ago. FDA said at the time that, while additional tests went on, patients should continue using their replacements. The agency decided that, until it had more information, not using devices could prove “more harmful” to patient health. Since then, the FDA has not provided new information on the test results.
But separate from the foam issue, the FDA recently warned about safety risks from replacement DreamStation 2 devices due to the potential for overheating, leading to burns, smoke and fire.
You can read the latest report fromProPublica and the Pittsburgh Post-Gazette at ProPublica‘s website.
Timeline: How the Philips Respironics respiratory devices recall unfolded
