Official recall record
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2025-03-21
- Country of alert
- China
- Alert level
- Class I
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00195278569677
- Brand on record
- GE Medical Systems China Co., Ltd.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2025-11-14 · US FDA — Medical Devices
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9 - 2025-05-16 · US FDA — Medical Devices
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system - 2025-03-21 · US FDA — Medical Devices
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200
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