HARRISBURG, Pa. (WHTM) — Philips is recalling specific mechanical ventilators over concerns of possible carcinogenic effects.
According to the U.S. Food and Drug Administration, specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices were recalled.
The order identifies potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in the devices.
The company says it has produced millions of Bi-Level PAP, CPAP and mechanical ventilator devices using the PE-PUR sound abatement foam but despite the large quantity, the complaint rate was relatively low at 0.03% in 2020. Regardless, Philips tests determined possible risks remain.
The recalls says the PE-PUR foam may degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the user
Potential risks include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. To date, there have been no reports of death as a result of these issues.
The company continues to monitor reports of potential safety issues as required by rules regulations,
“We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety,” CEO of Royal Philips, Frans van Houten said.
He added “In consultation with the relevant regulatory agencies and in close collaboration with our customers and partners, we are working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices. Patient safety is at the heart of everything we do at Philips.”