Philips manufacturing has recalled many of their sleep apnea machines and ventilators after it was discovered they may contain foam that could put users at risk of cancer or other health issues. The Dutch company announced a U.S. recall for millions of units of the Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices. Most of them are DreamStation products.

The suspected defect is related to the inclusion of polyester-based polyurethane sound abatement foam in the devices. Over time it’s been shown that as the foam degrades it can cause harmful effects when cleaned in the wrong way or when exposed to high heat and humidity.  Philips said there have been no reports of deaths. Phillips also warned of the potential risks of particulate exposure include "headache, irritation, inflammation, respiratory issues and possible toxic and carcinogenic effects." Phillips also noted: "The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects. Philips has received no reports regarding patient impact related to chemical emissions."

Phillips says they will replace the current sound-abatement foam with a new material. “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 Monday in a statement. “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." Users of the CPAP device have been advised to consult with their physician about the need to adjust their treatment plans. In some cases, the benefits of continuing to use the devices "may outweigh the risks," Philips said.

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