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→Impacted Devices
As a result of extensive ongoing analysis following this announcement, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (Outside of U.S.) for specific affected devices.
===Health Issues===
As reported by Philips Respironics
These issues (degrading foam and/or off-gassing) can result in
* serious injury which can be life-threatening,
* cause permanent impairment,
* and/or require medical intervention to preclude permanent impairment.
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.
The potential risks of particulate 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.
The potential risks of chemical exposure due to off-gassing include:
* headache/dizziness,
* irritation (eyes, nose, respiratory tract, skin),
* hypersensitivity,
* nausea/vomiting,
* toxic and carcinogenic effects.
There have been no reports of death as a result of these issues.
===Impacted Devices===
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