Sam Brusco, Associate Editor08.30.22
The U.S. Food and Drug Administration (FDA) announced that Philips Respironics recalled certain bi-level positive airway pressure (Bilevel PAP, BiPAP, or BPAP) machines over a plastic that might be contaminated with a “non-compatible material.”
If the plastic is in the device’s motor, it could release volatile organic compounds (VOCs). The plastic may also make the machine fail and stop working suddenly during use. Potential risks include: headache; dizziness; eye, nose, airway, or skin irritation; hypersensitivity reaction; nausea or vomiting; or toxic and cancer-causing effects.
There have been no reports yet of injury or death associated with the issue, according to FDA.
According to FDA, this recall isn’t associated with the PE-PUR foam issue impacting certain BiPAP machines recalled in June 2021, described in the Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication.
This new recall does apply to some of the devices recalled in June 2021, however.
386 affected BiPAP machines were distributed in the U.S. between August 6, 2020 and September 1, 2021. Philips sent affected customers a recall letter on August 26 of this year. The recalled models are listed below, but only machines with serial numbers identified in the company’s recall letter are affected:
If the plastic is in the device’s motor, it could release volatile organic compounds (VOCs). The plastic may also make the machine fail and stop working suddenly during use. Potential risks include: headache; dizziness; eye, nose, airway, or skin irritation; hypersensitivity reaction; nausea or vomiting; or toxic and cancer-causing effects.
There have been no reports yet of injury or death associated with the issue, according to FDA.
According to FDA, this recall isn’t associated with the PE-PUR foam issue impacting certain BiPAP machines recalled in June 2021, described in the Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication.
This new recall does apply to some of the devices recalled in June 2021, however.
386 affected BiPAP machines were distributed in the U.S. between August 6, 2020 and September 1, 2021. Philips sent affected customers a recall letter on August 26 of this year. The recalled models are listed below, but only machines with serial numbers identified in the company’s recall letter are affected:
- A-Series BiPAP A30 (Ventilator)
- A-Series BiPAP A40 (Ventilator)
- A-Series BiPAP V30 (Auto Ventilator)
- OmniLab Advanced+