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.
What this means for you
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
- 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
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.
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