Medical equipment company Philips has recalled between 3 million and 4 million ventilators and continuous positive airway pressure (CPAP) machines.
The reason is due to a foam part that can degrade and pose a health risk, the company said, according to Reuters.
The foam is used to lower the sound emitted by the machines. In addition to the foam particles, the gases released by the foam breaking down could be toxic or cause cancer.
The foam degradation could be made worse if unapproved cleaning methods are used to sanitize the machines, Philips said in the recall announcement.
Most of the affected machines are from the first-generation of DreamStation products, according to Philips.
“We’re going to put all our capacity to focus entirely on replacing and repairing these units,” company Chief Executive Frans van Houten said, according to Reuters.
The process could take a year and that it “has a consequence that we will not be able to serve new customers, so there’s going to be a shortage in the field,” van Houten added.
About 80% of CPAP machines are affected, and customers are being told not to use them, but there have been no reports of deaths relating to the issues, Reuters reported.
People on the company’s recalled ventilators are being told to continue using them until they talk to a doctor about an alternate treatment. If there is no other alternate device, then a filter can be installed, the company said.
The company is working with heath officials to find a replacement foam that will have to undergo testing and regulatory review.
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Editor’s note: A previous version of this story listed affected products. The list was in error. For a complete list of all of the devices that are recalled, click here.
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