Philips has recalled about 3.5 million ventilation devices after finding a defect that could cause cancer, the company said June 14.
The ventilators use polyester-based polyurethane sound abatement foam, which has the potential to degrade into particles that could be ingested or inhaled and have toxic and carcinogenic effects, Philips said in a news release.
If the sound abatement foam gets into patients' airways, it can cause headache, irritation, inflammation and respiratory issues, according to Philips. The company said it expects costs related to fixing the issue to be roughly $605 million, Bloomberg reported.
The recall notification was issued only for the U.S., where about 65 percent of the devices were sold, according to Bloomberg. The rest of the world was issued a field safety notice.
Philips said it's working with regulators on a "comprehensive repair and replace program" for the affected devices.
"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," Philips CEO Frans van Houten said in a news release.
Read the full news release here.