CanadaThe Hamilton‑C2 Intensive Care Ventilator (model/catalogue 160001, all serial numbers) with the neonatal option installed is affected. When used cumulatively for 91 days with neonatal patients the device can switch to “ambient state,” causing an immediate stop of ventilation while sounding audible and visual alarms; Hamilton Medical AG previously issued field safety communications (CER 110972, May 2023 and FSCA‑2025‑01‑01, January 2025) and reports no new complaints since May 2023. Contact the manufacturer for additional information.
What's being recalled
Companies: Hamilton Medical Ag, Via Crusch 8, Bonaduz, Switzerland, 7402.
How to identify it
Affected products: Hamilton-C2 Intensive Care Ventilator; Lot or serial number: All lots.; Model or catalogue number: 160001
The hazard
Hamilton Medical AG became aware of a malfunction with HAMILTON-C2 ventilators when used long term with neonatal patients. If an affected HAMILTON-C2 ventilator is used cumulatively for 91 days with neonatal patient without a restart of the device, the device will switch to "ambient state", resulting in an immediate stop of ventilation. During the "ambient state" the device is alarming audibly and visually until it is switched off by the user. Hamilton Medical AG previously communicated this issue through FSCAs with reference CER 110972 (May 2023) and FSCA-2025-01-01 (January 2025). This updated FSN is provided with a new reference number and addresses only HAMILTON-C2 where the neonatal option is installed. Since the initiation of the first field action in May 2023, Hamilton Medical AG did not receive any new complaint related to the issue for HAMILTON-C2 devices.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States