Philips Respironics has issued an additional recall for certain Philips BiPAP (bilevel positive airway pressure) devices due to the potential to release volatile organic compounds (VOCs), according to an Aug 29, 2022 FDA alert.

The FDA reports that the BiPAP devices may contain a plastic contaminated with a non-compatible material. If that plastic is in the device motor, the FDA explained, it may release certain chemicals of concern called volatile organic compounds (VOCs) and may also cause the machine to fail and stop working suddenly during use.

The FDA noted that this recall is not associated with the PE-PUR foam issue impacting certain BiPAP machines recalled in June 2021. However, this new recall does apply to some of the devices recalled in June 2021.

According to the FDA, Philips distributed 386 affected BiPAP machines in the US 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.

  • 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.

Recommendations for Healthcare Providers

Locate all recalled devices in your facility.

  • 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 recall issued by Philips Respironics. Replace these devices with an unaffected device or discuss with your patient (or their caregiver, as appropriate) whether their plan for care and treatment should change as a result of this recall.
  • The A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator) machines, which are intended for use in either clinical environments or by patients at home, were also included in the June 2021 recall issued by Philips Respironics. For health care providers who have patients using an A-Series BiPAP A30 (Ventilator) or A-Series BiPAP A40 (Ventilator) machine:
    • 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.
    • If the device was not already corrected or replaced through the June 2021 recall, register the device, if not done already, on the Philips website and discuss with your patient the best treatment course.

If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, we encourage you to report any health issues or problems with the device through the MedWatch Voluntary Reporting Form.