Recall Z-2796-2018— Hamilton Medical AG

Name: FDA recall Z-2796-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-09

Class II · Terminated

Class II FDA medical device recall by Hamilton Medical AG, initiated 2018-03-09, terminated 2019-03-18. It names one FDA 510(k) clearance: K161450. Product: Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room, and during transfer of ventilated patients within the hospital.. 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..

Recalling firm: Hamilton Medical AG
Classification: Class II
Status: Terminated
Initiated: 2018-03-09
Terminated: 2019-03-18
Firm location: Bonaduz, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K161450 — HAMILTON-C3Hamilton Medical AG·cleared 2017-04-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.