Hamilton-C2/C3/C1/T1 ventilators
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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 |
Hamilton-C2 With Neonatal Option |
Contact the manufacturer. |
160001 |
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
Hamilton Medical AG
Via Crusch 8, Bonaduz, Switzerland, 7402
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