Agency classClass IIOur severity:High FDA (Devices)·Z-2796-2018·Announced 2018-08-22

Hamilton-C3 Ventilator Recalled Due to Control Board Component Defect

Hamilton Medical AG is recalling two Hamilton-C3 ventilators because an out-of-specification control board component may cause the device to shut down and trigger alarms.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device (ventilator) where a defect could cause a shutdown, but the source text does not report any injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Hamilton Medical AG is recalling two units of the Hamilton-C3 Ventilator. The recall is due to an out-of-specification component on the control board. This defect may cause the ventilator to open the inspiratory channel and the expiratory valve, leading to a device shutdown. When this occurs, the ventilator activates an emergency buzzer and a blinking alarm LED on the front of the device.

The affected devices are identified by serial numbers 3084 and 3088. The Hamilton-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants, and neonates. These devices are used in intensive care wards, intermediate care wards, emergency wards, long-term acute care hospitals, recovery rooms, and during patient transfers.

The recall covers two devices distributed in the United States to California, Colorado, Illinois, Louisiana, Minnesota, New York, Oklahoma, Virginia, and Wisconsin. The devices were also distributed worldwide to China, Germany, India, Indonesia, Israel, Kazakhstan, Korea, Pakistan, Taiwan, Poland, and Armenia. Healthcare facilities should stop using the affected units and contact the manufacturer for instructions.

The recalled product

Product: Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care…
Manufacturer: Hamilton Medical AG
Category: Medical Device — Ventilator
Hazard: device-malfunction
unexpected-shutdown
Affected units: 2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Serial Number: 3084
3088

Distribution

Distributed in 9 states:

Part of a larger recall action

This product is one of 2 recalled by Hamilton Medical AG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Hamilton Medical AG

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