Reminder: Philips Respironics Has Issued a Recall on the Following BiPAP Devices
The FDA alerts patients, caregivers, and health care providers that Philips Respironics recalled certain BiPAP machines that may contain contaminated plastic in the device motor, which could release volatile organic compounds (VOCs) or cause the machine to fail suddenly.
The following notice was issued by the Food & Drug Administration (FDA) on August 29, 2022:
The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. 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.
This recall is not 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. However, this new recall does apply to some of the devices recalled in June 2021.
Philips distributed 386 affected BiPAP machines in the U.S. between August 6, 2020, and September 1, 2021. On August 26, 2022, Philips sent affected customers, including Durable Medical Equipment (DME) suppliers, an Urgent Medical Device Recall letter. The models, some of which are intended for use only in clinical environments, are listed below; however, only machines with the serial numbers identified in the company's Urgent Medical Device Recall letter are affected by this recall.
Affected models:
- A-Series BiPAP A30 (Ventilator)
- A-Series BiPAP A40 (Ventilator)
- A-Series BiPAP V30 (Auto Ventilator)
- OmniLab Advanced+
Recommendations for Patients and Caregivers
The A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator) machines were also included in the June 2021 recall issued by Philips Respironics. If you have an A-Series BiPAP A30 (Ventilator) or A-Series BiPAP A40 (Ventilator) machine:
- No action is needed, if your device was corrected or replaced through the June 2021 recall, as the affected plastic components were also replaced.
- If your device was not already corrected or replaced through the June 2021 recall, register your device on the Philips website if you have not done so already, and talk with your health care provider to decide if the plan for your care and treatment should change as a result of this recall.
- If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk with your health care provider and report the issue or problem through the MedWatch Voluntary Reporting Form.