On September 23, 2022, the U.S. Food and Drug Administration (FDA) issued a Class I recall, its most serious type of recall, for certain Philips Respironics bi-level positive airway pressure (BiPAP, BPAP, or Bilevel PAP) machines. This recall was the fifth Class I recall for Philips ventilators in 2022. The September 2022 recall is not […]
On September 23, 2022, the U.S. Food and Drug Administration (FDA) issued a Class I recall, its most serious type of recall, for certain Philips Respironics bi-level positive airway pressure (BiPAP, BPAP, or Bilevel PAP) machines. This recall was the fifth Class I recall for Philips ventilators in 2022.
The September 2022 recall is not associated with the June 2021 recall around PE-PUR foam impacting certain BiPAP machines. The recall of 5.2 million Philips respiratory devices has attracted more attention, from the public as well as the U.S. Department of Justice. In total, Philips Respironics filed about 99,000 Medical Device Reports (MDRs) with the U.S. Food and Drug Administration (FDA) between April 2021 and December 2022.
The September 2022 recall can apply to certain BiPAP devices that were recalled last June 2021, many of which are still in use. It also applies to other breathing devices not covered by the June 2021 notice.
The new FDA warning states that certain breathing machines were manufactured with plastic that was contaminated with non-compatible, potentially toxic plastic. The letter warns that the toxic plastic is in the device motor, and toxic volatile organic compounds (VOCs) can be released while using the breathing machine. Moreover, the plastic could cause the breathing machine to fail and stop operating during use.
Philips sold almost 1,700 of these recalled BiPAP machines between August 6, 2020 and September 1, 2021. Philips will provide affected customers and suppliers with an Urgent Medical Device Recall letter. The BiPAP models are detailed below. However, only Philips BiPAP machines with the serial numbers specified in Philips’ Urgent Medical Device Recall letter are involved with this recall.
The FDA and Philips have issued the following safety recommendations for those affected by the recalled BiPAP machines:
Health Care Providers are urged to locate any recalled devices in their facility.
The FDA also urges people harmed by a device to report these health issues on the MedWatch Voluntary Reporting Form.
Previously, Philips recalled
The Philips BiPAP machines that are being recalled might contain plastic contaminated with toxic volatile organic compounds (VOCs). The possible risks of inhaling VOCs include:
The FDA acknowledges that patients depend on these breathing machines, and they are monitoring Philips’ actions to make sure that the issues are corrected as soon as possible. The FDA is also reviewing Philips’ strategy to address the problem.
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