Health product recall

Hamilton-C2/C3/C1/T1 ventilators

Last updated

Summary

Product
Hamilton-C2/C3/C1/T1 ventilators
Issue
Medical devices - Performance issue
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

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe