FDADecember 15, 2015device

Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ASSY-MSN, VENT ENGINE ASSY 7900, 1009-8216-000 ASSY-MSN, VENT ENGINE ASSY AESPIRE 7900 1009-8423-000 ASSY-MSN, VENT ENGINE ASSY, AESTIVA 7900 MRI 1503-8102-000 ASSY-MSN, VLV ASSY DR GAS CHK BCG, Manufacturing assembly - Buy...

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

1503810100010098216000150381020001503300600010098423000

Recall history

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

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