The FDA has issued a Class I recall designation for the correction, which addresses a fault that can cause ventilation to stop unexpectedly.
Hamilton Medical AG is issuing a correction for its Hamilton-C6 ventilators after identifying a defect that could cause the device to fail, interrupting patient ventilation. The US Food and Drug Administration (FDA) has identified this as a Class I recall, its most serious designation.
The issue stems from certain ESM circuit boards that may have mechanical pre-damage originating from the supplier’s printed circuit board (PCB) separation process. According to the FDA notice, this defect can lead to a short circuit, which may prevent the ventilator from starting up or cause it to enter an “ambient state” during use.
An interruption in ventilation poses significant risks to patients, potentially causing respiratory failure, low blood oxygen, organ damage, or death. To date, there have been no reports of injuries or fatalities related to this issue.
The Hamilton-C6 is a facility-use ventilator designed for adults, pediatrics, and neonates in settings such as intensive care units, emergency wards, and during intra-hospital transport.
Action Required for Affected Devices
On June 3, 2025, Hamilton Medical sent an “Urgent Medical Device Correction” letter to all affected customers. Users are advised to identify any affected Hamilton-C6 ventilators in their inventory and coordinate with their local Hamilton partner. The correction involves replacing the faulty ESM circuit board with a new one, a task that must be performed by a trained service technician.
Customers in the US with questions regarding the correction can contact the Hamilton Medical AG Vigilance Team via email.
ID 78883741 | Concept © Anutr Yossundara | Dreamstime.com
