Health product recall

Omnilab Advanced Domestic and Omnilab Advanced Domestic Core

Last updated

Summary

Product
Omnilab Advanced Domestic and Omnilab Advanced Domestic Core
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Affected products

Affected products

Lot or serial number

Model or catalogue number

Omnilab Advanced, Domestic Core

All lots.

1111123
1111124

Omnilab Advanced, Domestic

All lots.

1111122

Issue

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.

• 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.

• 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).

• 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 25, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
Respironics Inc. Also Trading As Philips Rs North America Llc
1001 Murry Ridge Lane, Murrysville, Pennsylvania, United States, 15668
Published by
Health Canada
Audience
General public
Recall class
Type I
Identification number
RA-75324

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