The recall notification (U.S. and Canada) / field safety notice (International Markets) informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. High heat and high humidity environments may also contribute to foam degradation in certain regions.
Philips continues to monitor reports of potential safety issues through our post-market surveillance activities as required by medical device regulations and laws in the markets in which we operate.
In the event of exposure to degraded foam:
- The potential risks of degraded foam exposure include:
- Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic affects.
- To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection.
In the event of exposure to chemical emissions:
- The potential risks of exposure due to chemical emissions from affected foam include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects.
- To date, Philips has not received reports of patient impact or serious harm as a result of this issue.