NETHERLANDS – Dutch medical equipment company Philips has recalled some breathing devices and ventilators because of a foam part that might degrade and become toxic, potentially causing cancer.
Philips Chief Executive, Frans van Houten, who said the company was one of the largest makers of sleep apnea machines and ventilators, recounted that up to 4 million worth of equipment will be recalled.
Foam used to dampen the machines’ sound can degrade and emit small particles that irritate airways, the group said, as it announced the recall. Gases released by the degrading foam may also be toxic or carry cancer risks.
The group took a $303 million charge for the issue after announcing an identical provision in its first quarter-earnings report in April, bringing the total cost of the problem to 500 million euros to date.
“We’re going to put all our capacity to focus entirely on replacing and repairing these units,” Van Houten said in a call, a process he said would likely take a year.
This recall is likely to cause a shortage in the field, especially at this time when there is a high demand for ventilators dur to the coronavirus pandemic.
Company spokesman Steve Klink said about 80% of the affected devices were machines used to help people with sleep apnea, known as Continuous Positive Airway Pressure (CPAP) machines.
Users of those machines were advised to halt usage. Around two-thirds of Philips CPAP machine sales are in the United States.
The other 20% of affected devices were ventilators. Doctors and patients using life-sustaining ventilators should first consider whether the potential danger from the foam outweighs other risks, the company said.
The global ventilator market value is estimated to have exceeded $4.7B during 2020 as a result of the sudden spike in demand for treating COVID-19 patients. Many countries reported shortages in ventilators, pummeling the market value as well as pushing producers, such as Philips, to increase capacity.
“Philips has received reports of possible patient impact due to foam degradation,” the company said in a statement. “To date, there have been no reports of death as a result of these issues.”
Spokesman Klink said Philips had received some complaints about the devices, representing 0.03% of those sold in 2020.
The company said the matter would cause revenue headwinds in the division making the devices but that would be compensated by strength in other businesses.
Philips said it was working with health authorities on a safe replacement for the foam, but that it must first clear testing and regulatory hurdles.