Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern

Original Post

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product 

• Product Name: Philips Respironics BiPAP A30, A40, V30, and OmniLab Advanced+
• Product Models:
  • A-Series BiPAP A30 (Ventilator)
  • A-Series BiPAP A40 (Ventilator)
  • A-Series BiPAP V30 (Auto Ventilator)
  • OmniLab Advanced+
• Serial Numbers: See recall database entry.
• Only machines with serial numbers identified in the company’s communications are affected by this recall. 
• Distribution Dates: August 6, 2020, to September 1, 2021
• Devices Recalled in the U.S.: 386
• Date Initiated by Firm: August 26, 2022

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.

Device Use

A bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machine pumps air under varying pressure into the airway of the lungs. BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. These devices are prescribed for people with obstructive sleep apnea syndrome to keep their airways open during sleep, for those who have respiratory insufficiency (not enough oxygen breathed in or carbon dioxide breathed out), or respiratory failure (stop breathing). BiPAP machines may be used to treat adult and pediatric patients at home and in clinical environments, such as hospitals and sleep laboratories, depending on the instructions for use for the particular device model. 

Reason for Recall

Philips Respironics (Philips) is recalling certain BiPAP 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. 

The potential risks of inhaling VOCs include:

• Headache
• Dizziness
• 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

If the plastic causes the machine to fail and stop working suddenly, it may also lead to serious injury or death.

The FDA is not aware of any reports of serious injury or death associated with the recalled BiPAP machines due to the contaminated plastic issue.

Who May be Affected

• People who receive breathing support from the affected Philips BiPAP (ventilator) machines.
• Health care personnel providing care for patients who receive breathing support from the affected Philips BiPAP (ventilator) machines. 

What to Do 

Phillips sent affected customers an Urgent Medical Device Recall letter on August 26, 2022. The contacts included Durable Medical Equipment (DME) suppliers. The letter offered the following recommendations.

For health care providers: 

Locate all recalled devices.

• A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ machines are used in clinical environments only
  • Replace these devices with an unaffected device.
  • Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall.
• A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator) are used in clinical environment and home care settings
  • No action is needed if the device was 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 on the Philips’ website if you have not done already.
  • Discuss the best treatment course with the patient.

For patients and caregivers: 

• A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator)
  • No action is needed if the device was 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 your device on the Philips’ website if you have not done so already.
  • Talk with health care providers to decide if your care and treatment should change as a result of this recall.

The FDA also issued a safety communication, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue, for health care providers, patients and their caregivers.

Contact Information

Customers who need any further information or support should contact Philips Recall Support at 1-877-387-3311 or email at [email protected].

Additional Resources: 

• Medical Device Recall Database Entry 
• Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication
• FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.