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Hamilton Medical AG recalls Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure venti
Recalled August 22, 2018 · FDA recall Z-2795-2018 · Hamilton Medical AG
Hazard
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. · FDA Class II
Units
16 devices
Sold at
US distribution to CA, CO, IL, LA, MN, NY, OK, VA, WI. Worldwide distribution to China, Germany, India, Indonesia, Israel, Kazakhstan, Korea, Pakistan, Taiwan, Poland, Armenia.
Description
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.
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.
Manufacturer(s)
Hamilton Medical AG
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →