Recall Monitor
Health ProductsType I recall

Hamilton C2 and C3 Intensive Care Ventilators

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Anaesthesiology
Product: Hamilton C2 and C3 Intensive Care Ventilators
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type I
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Products

Affected productsLot or serial numberModel or catalog number
Hamilton-C2 Intensive Care VentilatorContact the manufacturer.160002
Hamilton-C3Contact the manufacturer.160005

Issue

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

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