June 15, 2021 – Dutch medical gear producer Philips is recalling CPAP machines, ventilators, and different respiratory gadgets resulting from issues that the sound-reducing foam within the gadgets might degrade and be inhaled by customers, thereby that might trigger well being dangers, together with most cancers, the corporate mentioned in a press launch.
Philips chief govt Frans van Houten mentioned between three million and four million can be withdrawn, in response to Reuters.
Philips spokesman Steve Klink advised Reuters that roughly 80% of the affected gadgets had been CPAP (steady constructive airway strain) machines utilized by individuals with sleep apnea, with about two-thirds of machine gross sales. Philips CPAP in the US.
Ventilators make up the opposite 20%, the outlet reported, and a few BiPAP (bi-level constructive airway strain) machines had been additionally recalled.
The corporate will ship up to date working directions and restore and exchange the froth, the corporate mentioned. Regulatory companies have been notified.
Philips has produced thousands and thousands of gadgets that use Polyester-based Polyurethane (PE-PUR) sound lowering foam and the person can ingest a sure degraded foam and that foam can launch “sure chemical compounds,” in response to the press launch.
However there have been no stories of dying from these issues.
Signs of publicity to particles from the degraded foam embrace headache, irritation, irritation, respiratory issues and potential poisonous and carcinogenic results, the corporate mentioned.
If you happen to use life-sustaining gadgets akin to ventilators, it’s best to proceed to make use of them till you may have consulted with a healthcare supplier. However the firm recommends in opposition to utilizing bi-level PAP or CPAP gadgets and says it’s best to converse along with your physician.
The just lately launched next-generation CPAP platform, DreamStation 2, shouldn’t be included within the recall, Philips mentioned.
“We deeply remorse any issues and inconveniences that sufferers utilizing the affected gadgets will expertise as a result of proactive measures we introduced at present to make sure affected person security,” van Houten mentioned within the press launch.