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Philips respironics bipap and humidifiers
Official notice
2 May 2024
Last checked
2 May 2024
An official Health Canada notice concerns Philips respironics bipap and humidifiers. The affected products feature a ventilator inoperative alarm, which occurs when the ventilator detects an internal error or a condition that may affect therapy. This may manifest in the following ways: The device may reboot intermittently for 5-10 seconds (stops providing therapy, screen goes blank during the reboot, and there is a single audible alert), restarting therapy, and returning to delivering therapy with same patient settings. Or The device may reboot intermittently for 5-10 seconds (stops providing therapy, screen goes blank during the reboot, and there is a single audible alert), restarting therapy, and returning to delivering therapy but with factory default settings. Or When there are three (3) reboots within a 24-hour period, the device will enter a ventilator inoperative state (therapy stopped, audible and visual alarms present). Or The device may enter a ventilator inoperative state without a reboot preceding this condition. Any of the above scenarios could result in interruption and/or loss of therapy which may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients. Recall start date: March 19, 2024 Published 2024-05-02.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75470
Official notice
2024-05-02
The hazard
The hazard
The affected products feature a ventilator inoperative alarm, which occurs when the ventilator detects an internal error or a condition that may affect therapy. This may manifest in the following ways: The device may reboot intermittently for 5-10 seconds (stops providing therapy, screen goes blank during the reboot, and there is a single audible alert), restarting therapy, and returning to delivering therapy with same patient settings. Or The device may reboot intermittently for 5-10 seconds (stops providing therapy, screen goes blank during the reboot, and there is a single audible alert), restarting therapy, and returning to delivering therapy but with factory default settings. Or When there are three (3) reboots within a 24-hour period, the device will enter a ventilator inoperative state (therapy stopped, audible and visual alarms present). Or The device may enter a ventilator inoperative state without a reboot preceding this condition. Any of the above scenarios could result in interruption and/or loss of therapy which may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients. Recall start date: March 19, 2024
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Philips.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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