Agency classClass IIOur severity:High FDA (Devices)·Z-2795-2018·Announced 2018-08-22

Hamilton-C1 Ventilator Recall Due to Control Board Component Defect

Hamilton Medical AG is recalling 16 Hamilton-C1 ventilators because a defective 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, representing a risk of harm to patients, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Hamilton Medical AG is recalling 16 Hamilton-C1 ventilator units. 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 and the activation of an emergency buzzer and blinking alarm LED.

The affected devices are distributed in the United States to California, Colorado, Illinois, Louisiana, Minnesota, New York, Oklahoma, Virginia, and Wisconsin. They are also distributed worldwide to China, Germany, India, Indonesia, Israel, Kazakhstan, Korea, Pakistan, Taiwan, Poland, and Armenia. The specific serial numbers for the recalled units are 12244, 12246, 12338, 12343, 12344, 12345, 12351, 12352, 12355, 12370, 12380, 12382, 12383, 12412, 12426, and 12432.

The Hamilton-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics in intensive care wards, recovery rooms, and during patient transfer. Healthcare facilities should check their inventory for these specific serial numbers and contact Hamilton Medical AG for further instructions on the recall.

The recalled product

Product: Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the recovery room, and during transfer of ventilated patients…
Manufacturer: Hamilton Medical AG
Category: Medical Device — Ventilator
Hazard: device-malfunction
ventilator-shutdown
Affected units: 16

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 (16)

Serial Number: 12244
12246
12338
12343
12344
12345
12351
12352
12355
12370
12380
12382
12383
12412
12426
12432

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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