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Health Canada Medical devices

Hamilton-C2/C3/C1/T1 ventilators

Issued September 26, 2023
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
Hazard description
Performance
Product
Product name
Hamilton-C2/C3/C1/T1 ventilators
Reference
ID
RA-73858