Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0755-2017 — GE Healthcare, Avance, Avance CS2, Amingo.

U.S. FDA — Device Enforcement · United States · 2016-11-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0755-2017
Date of alert
2016-11-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Reported risk: GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anesthesia devices can transition to a System Malfunction state if the lower storage drawer containing the optional large tray insert accessory closed with an abnormally high amount of force.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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