FDAMay 24, 2018device

Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respirato...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.

What to do

FDA enforcement status: Terminated

Brands named

draeger medicaldraeger

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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