FDAMay 24, 2018device

Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are...

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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