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Omnilab advanced domestic and omnilab advanced domestic core

Official notice

15 May 2024

Last checked

15 May 2024

Critical riskHealth Canada

An official Health Canada notice concerns Omnilab advanced domestic and omnilab advanced domestic core. 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 Published 2024-05-15.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75324

Official notice

2024-05-15

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. • 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

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

75324

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Affected products

Product 1

Affected products - Omnilab Advanced, Domestic Core, Lot or serial number - All lots., Model or catalogue number - 1111123 1111124

Product 2

Affected products - Omnilab Advanced, Domestic, Lot or serial number - All lots., Model or catalogue number - 1111122

Risk / 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. • 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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Philips, Omnilab Advanced Domestic And Omnilab Advanced Domestic Core.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

critical

Recall details

Recall number

75324

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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