Amid a recall that has already drawn the ire of federal regulators over the glacial pace with which it has handled remediation of the matter, Philips is facing an additional recall of some of its respiratory devices over an unrelated fault.
According to Reuters, the latest recall action targets 1,700 Philips respiratory devices around the world, with 386 of them located in the United States. The recall was issued over concerns that a specific plastic used in the device had been contaminated with a volatile organic compound. If that plastic was used in the motor of a respiratory aid device, the part could off-gas VOCs into the breathing circuit.
The FDA notes that this latest recall is not related to those that have plagued the company since it was discovered that the foam used to insulate Philips breathing machines and make them quieter was also carcinogenic and could cause cancer. At the same time, the agency says it is not willing to rule out the possibility that there are machines in use that are affected by both recalls.
Philips released a statement promising that “all affected devices with the non-conforming plastic will therefore be remediated in the June 2021 field action.” While it is unclear what was meant by a “2021 field action” as we approach the latter months of 2022, what is clear is that Philips’ history when it comes to handling recalls at scale leaves much to be desired.
Earlier this year, the FDA lambasted Philips over the pace with which it was remediating respiratory units affected by the foam recall that has plagued the company for over a year. The agency also threatened Philips with forced refunds of respiratory aids that had not been repaired, replaced, or remediated by the company if it failed to meet demands and submit a formal plan of action.