Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. Repairing and replacing the recalled devices. On June 14th, the company issued a recall notice for over a dozen of its ventilators and BiPAP and CPAP machines, which are used by millions of people at home, in hospitals, and in care. At the time the field safety notice was issued, Philips Respironics relied on an initial, limited data set and toxicological risk assessment. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Repair and Replacement On May 2, 2022, the FDA's Center for Devices and Radiological Health (CDRH) sent notice to Philips that CDRH is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act [a 518(b) order], to require Philips to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015. Patients are advised to log into the Patient Portal to view approximate shipping timeframe of their replacement device. UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and What happens after I register my device, and what do I do with my old device? 1-800-542-8368. In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). As a CPAP recall drags on, sleep apnea sufferers are getting angry. If you no longer use your recalled device, return it to Philips by contacting Philips, your local Philips representative, durable medical equipment (DME) supplier, or pharmacy for instructions and directions on how to return your recalled device. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website.

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