Philips Respironics - Certain CPAP and Bi-Level PAP Devices
Published 27 July 2021
Product
Philips Respironics - Certain CPAP and Bi-Level PAP Devices E30 (Emergency Use Authorization) DreamStation ASV DreamStation ST, AVAPS SystemOne ASV4 C-Series ASV C-Series S/T and AVAPS OmniLab Advanced+ SystemOne (Q-Series) DreamStation DreamStation Go Multiple Product Codes (See attached Product code list) All devices manufactured before 26 April 2021 ARTGs: 133792, 209934, 235674, 257012, 257013, 295664, 285420, 327227, 335508
Why it was recalled
The polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non-Continuous Ventilators may: 1. Degrade into particles which may enter the device's air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and 2. Emit certain chemicals (volatile organic compounds or VOCs).
Hazard
Foam degradation: 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 effects. VOC emission: 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.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.