FDA: Class I recall of G5 Ventilators by Hamilton

Editor's Note

The Food and Drug Administration on November 13 identified the recall of Hamilton G5 Ventilators V2.00 and V2.31 as Class I, the most serious.

The ventilator may stop working, without sounding an alarm, when the oxygen enrichment key is pressed to attach the mask to the patient.

If the device operator does not intervene, the patient may not receive enough oxygen and suffer serious adverse health consequences, including injury or death.

Hamilton Medical (Bonaduz, Switzerland) has received one report of device malfunction. No injuries or deaths were reported. 

Includes V2.00 and V2.31 [Posted 11/13/2015] AUDIENCE: Risk Manager, Nursing ISSUE: The ventilator may stop working without sounding an alarm when the device operator presses the oxygen enrichment key to attach the ventilator mask to the patient (suctioning maneuver).