Philips Respironics has recalled certain BiPAP devices because they might contain plastic contaminated with a non-compatible material that could ultimately impact patients’ health. This recall is not related to the PE-PUR foam-related recall Philips started in June 2021.
Globally, the recall affects 1,700 devices, with it impacting 386 BiPAPs sold in the United States between Aug. 6, 2020, and Sept. 1, 2021. Models included in the recall include:
- A-Series BiPAP A30 (Ventilator)
- A-Series BiPAP A40 (Ventilator)
- A-Series BiPAP V30 (Auto Ventilator)
- OmniLab Advanced+
Click for a downloadable table of brand names, model numbers, and serial numbers.
The BiPAPs included in the recall might contain plastic contaminated with a non-compatible material. According to a statement from the FDA, If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). The plastic may also cause the machine to fail and stop working suddenly during use.
The FDA warned the potential risks of inhaling VOCs include the following:
- Irritation in the eyes, nose, respiratory tract (airway), and skin
- Hypersensitivity reaction, such as an allergic reaction or another immune system reaction
- Nausea or vomiting
- Toxic and cancer-causing effects
The FDA released a lengthy safety communication on the recall, with information for patients, caregivers, and providers with device-specific instructions. In its recommendations for providers, the FDA advised:
The A-Series BiPAP V30 (auto ventilator) and OmniLab Advanced+ machines, which are intended for use only in clinical environments, are not a part of the June 2021 foam recall. Providers should replace these devices with unaffected devices or discuss with patients (or their caregivers) whether their plan for care and treatment should change as a result of the recall.
The A-Series BiPAP A30 (ventilator) and A-Series BiPAP A40 (ventilator) machines, which are intended for use in either clinical or home environments, were included in the June 2021 foam recall. No action is needed if the device was already corrected or replaced through the June 2021 recall (as the affected plastic components were also replaced). However, if the device was not already corrected or replaced via the June 2021 recall, register the device on the Philips websiteExternal Link Disclaimer and discuss with the patient the best treatment course.