Health product recall

Hamilton-C2/C3/C1/T1 ventilators

Last updated

Summary

Product
Hamilton-C2/C3/C1/T1 ventilators
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Numéro de série ou de lot Numéro de modèle ou de catalogue
Hamilton-C1 With Neonatal Option Contact the manufacturer. 161001
Hamilton-T1 With Neonatal Option Contact the manufacturer. 161006 161009
Hamilton-C2 With Neonatal Option Contact the manufacturer. 160001 160002
Hamilton-C3 With Neonatal Option Contact the manufacturer. 160005

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

Hamilton Medical AG

Via Crusch 8, Bonaduz, Switzerland, 7402

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-73858

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