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 is the fifth Class I recall for Philips ventilators the year.
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. This latest 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.
- Philips A-Series BiPAP A30 (Ventilator)
- Philips A-Series BiPAP V30 (Auto Ventilator)
- Philips A-Series BiPAP A40 (Ventilator)
- Philips OmniLab Advanced+
The FDA and Philips have issued the following safety recommendations for those affected by the recalled BiPAP machines:
- The Philips A-Series BiPAP A30 and A-Series BiPAP A40 Ventilator machines were part of the June 2021 recall. If your ventilator was replaced or corrected during the June 2021 recall, the potentially toxic plastic components were replaced. For devices that have not been repaired or replaced, register your ventilator on the Philips website, and speak with your doctor about treatment changes.
Health Care Providers are urged to locate any recalled devices in their facility.
- A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ breathing machines, which are used in clinical environments, are not affected by the June 2021 recall. All of these devices must be replaced with an unaffected device. Providers are urged to discuss the issue with their patients.
- A-Series BiPAP A30 and A-Series BiPAP A40 Ventilator machines are used in either patient-at-home care or clinical environments. They were included in Philips Respironics June 2021 recall. Healthcare providers with patients using A-Series BiPAP A40 and A-Series BiPAP A30 Ventilator machines that have been replaced or corrected in the June 2021 recall, the plastic components are safe and were replaced. If the ventilator was not corrected or replaced during the June 2021 recall, the device must be registered on the Philips website.
The FDA also urges people harmed by a device to report these health issues on the MedWatch Voluntary Reporting Form.
Previously, Philips recalled
Contaminated Plastic Used in Some Philips BiPAP Machines
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:
- Irritation in the nose, eyes, skin, and respiratory tract.
- Hypersensitivity reaction
- Vomiting or nausea
- Toxic effects
- Cancer-causing effects
- Death – when the machine stops working.
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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