Due to health risks – recall of CPAP and ventilators
In June 2021, an extensive recall of Philips and Löwenstein brand CPAP and ventilation devices was launched, which extended into 2022. The recall affected millions of devices worldwide and was one of the largest campaigns of its kind in the medical technology industry. Patients with sleep apnoea and those who were dependent on ventilator support were particularly affected
This was triggered by the discovery that the polyester-based sound-absorbing foam (PE-PUR) used in the devices could break down into particles and be inhaled or swallowed by patients. There was also the possibility that the foam was releasing certain chemicals.
The potential health risks associated with the disintegration of the PE-PUR foam and the release of chemicals were varied and potentially serious. The risks identified included:
- Irritation and inflammation in the respiratory tract caused by inhaled foam particles
- Headaches, nausea and vomiting due to particle exposure or chemical exposure
- Hypersensitivity and allergic reactions to the chemicals released
- Toxic effects from the chemicals and particles in the body
- Of particular concern: the possible carcinogenic potential of the released substances
