FDA Releases Philips Recall FAQ

Philips Respironics has had to recall a number of bi-level positive airway pressure (BiPAP or BPAP) machines and continuous positive airway pressure (CPAP) machines due to health risks assessed by the U.S. Food and Drug Administration (FDA).

Following these recalls and several efforts to increase consumer awareness about the dangers of these products, the FDA has released a guide to determining if a Philips Respironics machine was recalled and what the risks are of using these recalled devices, among other topics.

In June 2021, the FDA announced that Philips Respironics would have to recall a number of BiPAP and CPAP machines. In October of that same year, a class-action lawsuit was brought against the company alleging that the foam degradation had caused cancers and other illnesses. According to the FDA notice, “Philips has not yet provided the FDA with all information we requested to evaluate the risks from the chemicals released from the foam.”

In March 2022, the FDA ordered Philips to issue warnings to CPAP machine owners about the “unreasonable risk of substantial harm to the public health” that could occur if the polyester-based polyurethane foam used in those products to minimize sound degrades.”

This latest effort, released on May 19, includes a number of frequently asked questions in regards to the recall, including:

In general, the FDA advises patients to consult with its recommendations regarding ventilators as well as BiPAP and CPAP machines. Before stopping a BiPAP or CPAP regimen, the agency stresses the importance of consulting with a medical professional, and advises patients to register their machine with the “Urgent: Field Safety Notification” on the Philips Respironics website.

The FDA has continued to make efforts to analyze the situation with Philips Respironics. On May 2, the FDA’s Center for Devices and Radiological Health (CDRH) sent a notice to Philips Respironics proposing an order should be issued to require the company to submit a plan for the repair, replacement, or refund of all recalled devices manufactured after November 2015. Philips Respironics was given an opportunity to request an informal hearing on this matter but declined, stating instead that it will provide a written response to the agency.

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