FDADecember 15, 2015device

GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The dev...

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

The hazard

The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.

What to do

FDA enforcement status: Terminated

Brands named

ge medical systems

UPCs

1009901200010099212000

Recall history

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

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