Ge Medical Systems China recalls
Ge Medical Systems China appears in 27 official U.S. recall notices indexed by RecallRadar, most recently on 2026-06-10.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 27 |
|---|---|
| Published | 2018-02-21 to 2026-06-10 |
| By agency | FDA Device (27) |
| By classification | Class I (18), Class II (9) |
| By status | ongoing (24), terminated (3) |
| Distribution named in notices | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, PR, TN, TX, US, UT, VA, VT, WA, WI, WV |
Recalls
- MAC 5 A4 Resting ECG Analysis System 855001-001
FDA Device · Class II · 2026-06-10 · Ge Medical Systems China
Reason: Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-mak… - GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000
FDA Device · Class I · 2025-12-24 · Ge Medical Systems China
Reason: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia… - GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
FDA Device · Class I · 2025-12-24 · Ge Medical Systems China
Reason: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia… - GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222
FDA Device · Class I · 2025-12-24 · Ge Medical Systems China
Reason: Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia… - GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
FDA Device · Class II · 2025-07-02 · Ge Medical Systems China
Reason: GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz r… - GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog…
FDA Device · Class II · 2025-07-02 · Ge Medical Systems China
Reason: GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz r… - GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China
Reason: 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 Press… - GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China
Reason: 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 Press… - GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China
Reason: 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 Press… - GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China
Reason: 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 Press… - GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China
Reason: 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 Press… - GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China
Reason: 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 Press… - GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China
Reason: 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 Press… - GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China
Reason: 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 Press… - GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China
Reason: 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 Press… - GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China
Reason: 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 Press… - GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China
Reason: 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 Press… - GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China
Reason: 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 Press… - GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China
Reason: 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 Press… - GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China
Reason: 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 Press… - GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002
FDA Device · Class I · 2025-05-07 · Ge Medical Systems China
Reason: 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 Press… - F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
FDA Device · Class II · 2023-10-11 · Ge Medical Systems China
Reason: There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the… - GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
FDA Device · Class II · 2018-09-05 · Ge Medical Systems China
Reason: On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the… - GE Carestation 30 anesthesia systems
FDA Device · Class II · 2018-09-05 · Ge Medical Systems China
Reason: On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the… - GE 9100c NXT anesthesia systems
FDA Device · Class II · 2018-09-05 · Ge Medical Systems China
Reason: On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the… - Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2
FDA Device · Class II · 2018-02-21 · Ge Medical Systems China
Reason: Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems. - Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
FDA Device · Class II · 2018-02-21 · Ge Medical Systems China
Reason: Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.