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Hamilton-c2 c3 c1 t1 ventilators

Official notice

26 Sept 2023

Last checked

26 Sept 2023

High riskHealth Canada
Watch Hamilton Medical

An official Health Canada notice concerns Hamilton-c2 c3 c1 t1 ventilators. We have become aware of a malfunction with the Hamilton-C2/C3/C1/T1 ventilators when used long term in neonatal patient group. If an affected device is used accumulatively for 91 days in neonatal patient group without a restart of the device, the device will switch to "ambient state" and therefore stop ventilation. During the "ambient state" the device is alarming audibly and visually until it is switched off by the user. Hence, it is mandatory to apply a periodic preventive restart of affected devices. Devices and software version affected: All hamilton-C1/T1 with software version ≤2.2.10 and neonatal option installed All hamilton-C2 with software version ≤2.2.5 and neonatal option installed All hamilton-C3 with software version ≤2.0.9 and neonatal option installed Recall start date: June 1, 2023 Published 2023-09-26.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73858

Official notice

2023-09-26

The hazard

We have become aware of a malfunction with the Hamilton-C2/C3/C1/T1 ventilators when used long term in neonatal patient group. If an affected device is used accumulatively for 91 days in neonatal patient group without a restart of the device, the device will switch to "ambient state" and therefore stop ventilation. During the "ambient state" the device is alarming audibly and visually until it is switched off by the user. Hence, it is mandatory to apply a periodic preventive restart of affected devices. Devices and software version affected: All hamilton-C1/T1 with software version ≤2.2.10 and neonatal option installed All hamilton-C2 with software version ≤2.2.5 and neonatal option installed All hamilton-C3 with software version ≤2.0.9 and neonatal option installed Recall start date: June 1, 2023

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

73858

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Affected products

Product 1

Affected products - Hamilton-C1 With Neonatal Option, Numéro de série ou de lot - Contact the manufacturer., Numéro de modèle ou de catalogue - 161001

Product 2

Affected products - Hamilton-T1 With Neonatal Option, Numéro de série ou de lot - Contact the manufacturer., Numéro de modèle ou de catalogue - 161006 161009

Product 3

Affected products - Hamilton-C2 With Neonatal Option, Numéro de série ou de lot - Contact the manufacturer., Numéro de modèle ou de catalogue - 160001 160002

Product 4

Affected products - Hamilton-C3 With Neonatal Option, Numéro de série ou de lot - Contact the manufacturer., Numéro de modèle ou de catalogue - 160005

Risk / hazard

We have become aware of a malfunction with the Hamilton-C2/C3/C1/T1 ventilators when used long term in neonatal patient group. If an affected device is used accumulatively for 91 days in neonatal patient group without a restart of the device, the device will switch to "ambient state" and therefore stop ventilation. During the "ambient state" the device is alarming audibly and visually until it is switched off by the user. Hence, it is mandatory to apply a periodic preventive restart of affected devices. Devices and software version affected: All hamilton-C1/T1 with software version ≤2.2.10 and neonatal option installed All hamilton-C2 with software version ≤2.2.5 and neonatal option installed All hamilton-C3 with software version ≤2.0.9 and neonatal option installed Recall start date: June 1, 2023

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Hamilton Medical, Hamilton-c2 C3 C1 T1 Ventilators

Manufacturer

Not provided

Phone

Not provided

Brand: Hamilton Medical, Hamilton-c2 C3 C1 T1 Ventilators.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

73858

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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