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Hamilton c2 and c3 intensive care ventilators

Official notice

17 Feb 2025

Last checked

17 Feb 2025

High riskHealth Canada
Watch Hamilton Medical

An official Health Canada notice concerns Hamilton c2 and c3 intensive care ventilators. This field safety notice (FSN) provides an updated information on Hamilton medical ventilators Hamilton-C2/C3: Hamilton Medical AG became aware of a malfunction with our Hamilton-C2/C3 ventilators when used long term in neonatal patients. If an affected device Hamilton-C2 or Hamilton-C3 is used accumulatively for 91 days in neonatal patient 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 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-C2 with sw version ≤2.2.5 and neonatal option installed All Hamilton-C3 with sw version ≤2.0.9 and neonatal option installed Recall start date: January 29, 2025 Published 2025-02-17.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76965

Official notice

2025-02-17

The hazard

This field safety notice (FSN) provides an updated information on Hamilton medical ventilators Hamilton-C2/C3: Hamilton Medical AG became aware of a malfunction with our Hamilton-C2/C3 ventilators when used long term in neonatal patients. If an affected device Hamilton-C2 or Hamilton-C3 is used accumulatively for 91 days in neonatal patient 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 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-C2 with sw version ≤2.2.5 and neonatal option installed All Hamilton-C3 with sw version ≤2.0.9 and neonatal option installed Recall start date: January 29, 2025

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

76965

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Affected products

Product 1

Affected products - Hamilton-C2 Intensive Care Ventilator, Lot or serial number - Contact the manufacturer., Model or catalog number - 160002

Product 2

Affected products - Hamilton-C3, Lot or serial number - Contact the manufacturer., Model or catalog number - 160005

Risk / hazard

This field safety notice (FSN) provides an updated information on Hamilton medical ventilators Hamilton-C2/C3: Hamilton Medical AG became aware of a malfunction with our Hamilton-C2/C3 ventilators when used long term in neonatal patients. If an affected device Hamilton-C2 or Hamilton-C3 is used accumulatively for 91 days in neonatal patient 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 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-C2 with sw version ≤2.2.5 and neonatal option installed All Hamilton-C3 with sw version ≤2.0.9 and neonatal option installed Recall start date: January 29, 2025

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 And C3 Intensive Care Ventilators

Manufacturer

Not provided

Phone

Not provided

Brand: Hamilton Medical, Hamilton C2 And C3 Intensive Care Ventilators.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

76965

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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