FDA Class I Recall on G5 Ventilators by Hamilton

The G5 Ventilator V2.00 and V2.31, distributed between March 2007 & March 2014, are effected by this recall. The ventilator could stop working without sounding an alarm when the oxygen enrichment key (attached to the ventilator mask on the patient) is initiated by the operator.

This problem can occur in a couple of instances:

  1. When pressing the oxygen enrichment key a second time within 50 milliseconds after the disconnection is detected, or,
  2. When disconnection is detected immediately before the oxygen enrichment period automatically ends, so that detection of disconnection and termination of O2-enrichment occurs within 50 milliseconds of each other.

If one of these problems occur, the patient might not receive enough oxygen and could suffer serious adverse consequences, including injury or death.

For recommendations on what to do if this affect you and to learn more about the recall or report an issue, see the full post here.


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