The FDA’s Center for Devices and Radiological Health (CDRH) suggested this week that the agency issue an order requiring Philips, the manufacturer of recalled PAP devices manufactured after November 2015 to submit a plan for repair, replacement, or refund of the purchase price.
Due to potential health hazards, Philips Respironics voluntarily recalled some ventilators last year, bi-level positive airway pressure (also known as Bilevel PAP, BiPap, or BPAP) devices, and continuous positive airway pressure (CPAP) machines.
The polyurethane foam based on polyester that is used in medical devices to reduce sound and vibration can degrade. If this occurs, the individual using the device may breathe in or swallow black bits of foam or certain chemicals that are not visible.
Before the FDA decides whether to issue such an order, Philips has the right to an informal hearing.
The proposed order would be in addition to the FDA’s previous March action, which compelled Philips to notify customers of the recall and the health concerns posed by the recalled devices.
Read More on FDA’s website