Drug & Device Safety Atlas

FDA recall record · openFDA

GE Medical Systems China Co., Ltd.

22 FDA recalls on record (2023–2026) — 22 device. 22 still ongoing.

18
Class I (most serious)
4
Class II
0
Class III
22
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volu 15
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management b 3
GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 2
Software in development inadvertently made available for customer use. Use of this software version can result in clinic 1
There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE 1

Recalls

GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system. Class I 2025-03-21 GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system. Class I 2025-03-21 GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system. Class I 2025-03-21 GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system. Class I 2025-03-21 GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Class I 2025-11-14 GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system. Class I 2025-03-21 GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system. Class I 2025-03-21 GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system. Class I 2025-03-21 GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system. Class I 2025-03-21 GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system. Class I 2025-03-21 GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system. Class I 2025-03-21 GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Class I 2025-11-14 GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system. Class I 2025-03-21 GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system. Class I 2025-03-21 GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems Class I 2025-03-21 GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S Class I 2025-11-14 GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system. Class I 2025-03-21 GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system. Class I 2025-03-21 MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph Class II 2026-04-21 GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system Class II 2025-05-16 GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premie Class II 2025-05-16 F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) Class II 2023-09-08

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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