Philips sleep and respiratory care devices
This page is for the public, patients, and healthcare professionals.
It describes safety issues with sleep and respiratory care devices made by Philips Respironics.
What devices are affected by this safety issue?
Philips Respironics found safety issues with a number of sleep and respiratory care devices.
Patients may use these devices at home or in hospitals or care facilities.
These devices provide breathing support.
Affected devices are listed in Philips field safety notices here and here, and a HPRA safety notice.
What is the safety issue with affected Philips sleep and respiratory care devices?
Philips found two safety issues with these devices.
These issues relate to sound abatement foam, a part of the devices. These issues are:
- The foam may degrade into particles which can be inhaled or ingested by the user.
- The foam may emit certain chemicals during use of the device.
The risks of this issue are outlined in the notices above.
These risks include exposure to carcinogens which may affect users in the long term.
Philips received complaints about the presence of black debris within the air pathway circuit (extending from the device outlet, humidifier, tubing, and mask).
Philips also received reports of headache, upper airway irritation, cough, chest pressure and sinus infection.
Information for healthcare professionals
We advise healthcare professionals to:
We understand the manufacturer Löwenstein Medical has issued a similar notice for Somnia 3 (i) and Phoenix 3(i) CPAP devices.
The manufacturer has not placed affected devices on the Irish market.