Philips Respironics has announced that it is initiating a voluntary recall notification for Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator Devices, including DreamStation machines and System One machines). Philips Respironics takes patient safety very seriously, and is currently engaging with Australian regulatory bodies to rectify the issues. You can view the list of impacted machines, and FAQs here: www.philips.com/SRC-update.
This recall has been initiated by Philips due to two issues related to the sound abatement foam used in these devices. Firstly, this foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and secondly, the foam may off-gas certain chemicals. The breakdown of this foam may be exacerbated by unapproved cleaning methods, such as ozone.
The potential risks of exposure to the degraded foam include skin, eye and respiratory tract irritation, headache, asthma, toxic carcinogenic effects and adverse effects to other organs such as the kidneys and liver. So far, Philips has received several complaints regarding black debris within the air path circuit, and reports of headaches, coughing, chest pressure, and sinus infections.
The potential risks of exposure due to chemical emissions include headache/dizziness, irritation, hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. Philips has not receive any reports of serious harm from this issue to date.
Philips is currently recommending patients using affected BiLevel PAP and CPAP devices to discontinue use, and speak to their doctor about the benefits and risks of continuing therapy.
For patients using life-sustaining mechanical ventilator devices, Philips has recommended not to stop or alter prescribed therapy without having spoken to their doctor. Information about any action will be communicated by letter and website and where possible patients and customers will be contacted directly.
Sove CPAP Clinic is committed to working with Philips to ensure our affected customers are properly communicated with and supported during this time.