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Recall Observatory FDA recall evidence

Device 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.

Z-2795-2018

March 09, 2018

Class II

Product summary

Firm
Hamilton Medical AG
Event
Event 80467
Status
Terminated
Classification
Class II
Quantity
16 devices
Official record key
device-enforcement:Z-2795-2018

Official wording

Reason: 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.

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

Distribution pattern: 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.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification