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