PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 22, 2018 Initiated: March 9, 2018 #Z-2795-2018

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Hamilton Medical AG
Units Affected
16 devices
Distribution
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.
Location
Bonaduz

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Hamilton Medical AG. Units affected: 16 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 22, 2018. Severity: Moderate. Recall number: Z-2795-2018.

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