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

Recall Z-1625-2025 — GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002

U.S. FDA — Device Enforcement · China · 2025-03-21 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1625-2025
Date of alert
2025-03-21
Country / jurisdiction
China
Risk level
Class I
Risk type
recall
Brand
GE Medical Systems China Co., Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00840682124546
Reported risk: GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
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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