Health Canada recalls Philips sleep apnea devices due to malfunction concerns
Health Canada has issued a recall for Philips Respironics sleep apnea devices due to concerns over malfunctions.
The Omnilab Advanced titration system device was created to help regulate the breathing of apnea patients by providing a consistent airflow through a mask.
If activated, the device may reboot intermittently for a few seconds, interrupting the therapy. However, after rebooting, the machine will resume operation.
In some cases, the device may reboot and continue working but with factory default settings instead of the custom settings established for the patient.
Notwithstanding, Health Canada advises that this is not always the situation.
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If the machine experiences three reboots within 24 hours, it will enter a “ventilator inoperative state” or stop working, even without a reboot, as stated in the recall.
Health Canada cautions that any of the mentioned scenarios could result in therapy interruption or loss, potentially leading to various health risks for patients.
The recall covers all lot numbers of model 1044278.
Philips had previously recalled 35 other sleep apnea devices in 2021 due to foam breakage issues, which could be ingested by patients.
A class action lawsuit in British Columbia alleges that the company was aware of these issues for years, though these claims are pending in court and not yet proven.
The lawsuit asserts that the company delayed the recall until it had a new product available for purchase, rather than risk losing customers to competitors.
Philips maintains that upon investigating the complaints, they voluntarily decided to recall the devices.
Philips reports that 99% of the devices have been fixed by replacing the foam with silicone foam.
