June 14, 2021
The company issued the recall for affected Bi-Level PAP devices, CPAP devices, and mechanical ventilator devices on Monday, after determining that the PE-PUR sound abatement foam used in those devices not only may expose patients to noxious chemicals, but “may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user.”
“Despite a low complaint rate (0.03% in 2020), Philips determined, based on testing, that there are possible risks to users related to this type of foam,” the notice explained, adding that these included “headache, irritation, inflammation, respiratory issues … hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects.”
Up to four million devices could be affected by the re-call as the Covid-19 pandemic continues. Some of Philips’ breathing machines have been used to treat coronavirus patients around the world in cases where traditional, more invasive ventilators were deemed inappropriate for the situation. As Forbes reported, the lower-cost machines have also proved popular in countries such as India, due to a shortage of medical equipment.
Philips CEO Frans van Houten apologized for the re-call, claiming that the company deeply regretted “any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today,” and assuring consumers that “patient safety is at the heart of everything we do at Philips.”
The company is to replace the foam from both current and future devices with a new material that is in development, and assured its customers that no one had suffered fatal consequences from exposure to the foam that had been in use until now.