Philips Says Recalled Sleep Therapy Devices Unlikely to Harm Patients

Philips announced that independent testing on its recalled DreamStation devices showed that exposure from degraded sound abatement foam on the devices is unlikely to result in “appreciable harm” to patient health.

Five independent laboratories have conducted the testing and research program on the devices, and the results have been reviewed by third-party experts and an external medical panel, the company said.

Philips first warned of potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in specific CPAP, BiPAP and mechanical ventilator devices in April 2021, noting that the foam could potentially degrade into particles that had toxic and carcinogenic effects.

Philips issued a recall in June 2021 and by November the FDA said it had received more than 90,000 medical device reports, including 260 reports of deaths associated with the foam.