Philips (NYSE:PHG) has a new FDA Class I recall for its ventilators, adding to recall issues that have plagued the company for a year.
The FDA issued a notice alerting patients, caregivers and providers that certain Philips Respironics bi-level positive airway pressure (BiPAP or BPAP) machines may contain a plastic contaminated with a non-compatible material. If such plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). It may also cause the machine to fail and stop working suddenly during use.
FDA said the potential risks of inhaling VOCs include headaches, dizziness, irritation in the eyes, nose, respiratory tract and skin, hypersensitivity reactions, nausea or vomiting and toxic and cancer-causing effects. If the plastic causes the machine to fail and stop working suddenly, it may lead to serious injury or death.
At this stage, the FDA is not aware of any reports of serious injury or death associated with the recalled BiPAP machines due to the contaminated plastic issue.
Philips’ latest ventilator woes are unrelated to the ongoing recall of multiple respiratory devices due to polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. That recall, which dates back to June 2021, has led to high-level personnel changes and as recently as this month added affected users to its tally. To date, there have been 168 deaths, with 69,000 medical device reports (MDRs) filed related to that recall.
While the new Philips BiPAP machine recall is unrelated to the PE-PUR recall, it does apply to some of the devices involved. Philips distributed 386 affected BiPap machines in the U.S. between Aug. 6, 2020, and Sept. 1, 2021. It notified affected customers on Aug. 26, 2022, through an urgent medical device recall letter. Reuters reports that the recall affected 1,700 devices globally.
The following devices are affected by the recall:
- A-Series BiPAP A30 (Ventilator)
- A-Series BiPAP A40 (Ventilator)
- A-Series BiPAP V30 (Auto Ventilator)
- OmniLab Advanced+
The A-Series BiPAP A30 and A-Series BiPAP A40 were also among the affected devices in the June 2021 recall. No action is required if such a device was corrected or replaced through the June 2021 recall as the affected plastic components were also replaced, the FDA notice said.