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 notice and our HPRA safety notice available below.  

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.

What should I do if I am affected by this safety issue?

We advise the public to:

• Confirm if your device is listed on the Philips field safety notices linked above
• Read and follow HSE advice.
• Report any issues to us using our online form. 
• Register your device online at the request of Philips. If you cannot register online, you can ring 1800 851 241.
  

Information for healthcare professionals

We advise healthcare professionals to:

• Read and review HSE advice. 
• Read and review Philips information for clinicians.
• Report any safety issues to Philips.
• Report any safety issues to us using our online form.
  

Additional information

We understand the manufacturer Löwenstein Medical has issued a similar notice for Somnia 3 (i) and Phoenix 3(i) CPAP devices, available below. 

The manufacturer has not placed affected devices on the Irish market.