Philips Respironics is recalling certain bi-level positive airway pressure (BiPAP) machines that may contain a plastic contaminated with a non-compatible material.
The Food and Drug Administration announced the recall on Monday in a safety communication. The agency said that the recall isn’t related to Philips’ ongoing recall of millions of sleep apnea and ventilator devices due to sound abatement foam breaking down. However, some devices are affected by both recalls.
Certain BiPAP machines could contain contaminated plastic that “may release certain chemicals of concern called volatile organic compounds (VOCs)” if the plastic is in the device’s motor, according to the agency’s notice.
The risks of inhaling the VOCs include toxic and cancer-causing effects, headaches, dizziness and nausea or vomiting, among others.
The plastic also may cause the machines to suddenly stop working, which “may lead to serious injury or death,” the agency said. The FDA stated that it is not aware of any reports of serious injuries or deaths related to the issue.
Steve Klink, a Philips spokesperson, said in an emailed statement that the action is an expansion of an April 2021 recall of 43 BiPAP machines. Klink said that the recall now affects about 1,700 machines worldwide, including 386 in the U.S.
“Philips Respironics is advising customers to halt use of affected devices and return them to Philips Respironics for repair or replacement,” Klink wrote in the statement, adding that the company hasn’t received any reports of patient harm related to the issue.
BiPAP machines use varying levels of airway pressure to help patients with obstructive sleep apnea syndrome breathe both in and out during sleep, according to the FDA. The devices can be used by patients at home or in clinical settings such as hospitals or sleep laboratories.
Philips distributed 386 affected BiPAP machines in the U.S. between Aug. 6, 2020, and Sept. 1, 2021. The company sent a recall letter to customers on Aug. 26 notifying them of the issue.
The FDA said that four models are impacted by the recall:
- A-Series BiPAP A30 (Ventilator)
- A-Series BiPAP A40 (Ventilator)
- A-Series BiPAP V30 (Auto Ventilator)
- OmniLab Advanced+
The A-Series BiPAP A30 and A40 models are also included in the sleep apnea machine recall, according to the FDA.
The FDA is working with Philips about the recall and is reviewing the company’s strategy for addressing the problem. The agency is also determining if the problem violates FDA law or requirements and if assigning the recall a risk classification is necessary.
Philips has had multiple product safety issues over the last 18 months. Most notably, the company’s recall of over 5.5 million sleep apnea and ventilator machines, which was initiated in June 2021.
The recall has led to lawsuits, FDA facility inspections and a possible consent decree with the Department of Justice.
Between April 2021 and July 31, there were more than 69,000 medical device reports associated with the recall, including 168 reports of patient deaths.
Philips also recalled 56,671 V60 and V60 Plus ventilators in the U.S. for power issues that could cause the devices to shut down. As of April, there were four patient injuries and one death associated with the recall.
Amid Philips’ recalls, and broader business challenges, CEO Frans van Houten will be stepping down in October. Roy Jakobs, who currently leads Philips’ connected care unit, will take over the company.