medical Class II Updated 2018-08-22

Hamilton Medical AG recalls Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-

Recalled 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 within the hospital.

Hazard / Issue

An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providing an acoustic alarm and the blinking alarm LED on the device s front side.

Issued by

FDA

Affected States: CA, CO, IL, LA, MN, NY, OK, VA, WI

Lot/Code Info: Serial Number: 12244, 12246, 12338, 12343, 12344, 12345, 12351, 12352, 12355, 12370, 12380, 12382, 12383, 12412, 12426, 12432

View official government recall

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