Philips updates on CPAP, BiPAP and Mechanical Ventilator recall

 On June 14, 2021, Royal Philips' subsidiary Philips Respironics initiated a voluntary recall notification* for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. Following the substantial ramp-up of its production, service and repair capacity, the repair and replacement program in the US and several other markets is under way.

As expected, the FDA recently conducted an inspection of a Philips Respironics manufacturing facility in connection with the recall. The FDA provided a list of their observations to Philips Respironics, and in accordance with normal practice, Philips Respironics will submit its response to the inspectional findings for review by the FDA. Importantly, an FDA investigator's list of inspection observations does not constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. Additionally, the FDA has not changed its recommendation to patients and healthcare providers in relation to affected devices.

In June 2021, Philips Respironics initiated a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks, and is getting third-party expert assessments on this. Philips Respironics plans to make more data available to the relevant competent authorities as soon as possible after completing the assessment of the above mentioned research and tests, which is anticipated to take place in the fourth quarter.

Separately, Philips Respironics has conducted testing to support the new silicone replacement foam. Silicone foam testing provided by Philips Respironics to the FDA on devices authorized for marketing in the US had demonstrated adequate results. Philips Respironics continues to coordinate with FDA and other competent authorities on its testing.

Philips is committed to supporting the community of patients who rely on these devices, and the physicians and customers who are dedicated to meeting patient needs.

* Voluntary recall notification in the US/field safety notice outside the US

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