by John R. Fischer
, Senior Reporter | April 20, 2023
Philips says that 2.2 million respiratory devices it repaired or replaced in its 2021 major recall are now being used by patients in the U.S.
The company recalled 5.5 million CPAP and BiPAP machines, ventilators and other devices in June of that year after finding the sound abatement foam within them could break down and release particles that could enter a device’s airway pathway and become toxic.
Until recently, the company said on its site that 2.46 million devices had been repaired and replaced. But in a statement issued on April 13, the FDA said this number was “considerably less,” due to the amount listed including not only repaired devices that were sent back to customers, but also repair kits that Philips had sent to facilities to initiate repairs, according to Reuters
This, it said, could confuse users with affected devices. “We are concerned this may impact the estimated wait time for consumers still awaiting a replacement device.”
In response, Philips updated its site to say that 2.2 million repaired devices and replacements had been shipped to the U.S. “To date, we have consistently reported on the total amount of new replacement devices and repair kits that have been produced globally, as well as the total amount of new replacement devices and repair kits shipped to a given country of destination. This means that not all of these devices are already in the hands of patients.”
According to its site, Philips has developed approximately 2.8 million new devices and repair kits for U.S. registration demand, and made over 95% of new devices and repair kits for replacing the affected devices globally.