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GE Medical Systems China Co., Ltd. FDA Recalls

22 recalls on file across devices, 18 of them Class I and 22 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. ElectrocardiographClass IIApr 21, 2026Software in development inadvertently made available for cus
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Class INov 14, 2025Potential unexpected shutdown of Carestation 600 and 700 Ser
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Class INov 14, 2025Potential unexpected shutdown of Carestation 600 and 700 Ser
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-SClass INov 14, 2025Potential unexpected shutdown of Carestation 600 and 700 Ser
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana PremieClass IIMay 16, 2025GE HealthCare has become aware that the Estimated Fetal Weig
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound systemClass IIMay 16, 2025GE HealthCare has become aware that the Estimated Fetal Weig
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.Class IMar 21, 2025Certain Carestation 620/650/650c and 750/750c Anesthesia Del
GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.Class IMar 21, 2025Certain Carestation 620/650/650c and 750/750c Anesthesia Del
GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.Class IMar 21, 2025Certain Carestation 620/650/650c and 750/750c Anesthesia Del
GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system.Class IMar 21, 2025Certain Carestation 620/650/650c and 750/750c Anesthesia Del
GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.Class IMar 21, 2025Certain Carestation 620/650/650c and 750/750c Anesthesia Del
GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.Class IMar 21, 2025Certain Carestation 620/650/650c and 750/750c Anesthesia Del
GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.Class IMar 21, 2025Certain Carestation 620/650/650c and 750/750c Anesthesia Del
GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systemsClass IMar 21, 2025Certain Carestation 620/650/650c and 750/750c Anesthesia Del
GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.Class IMar 21, 2025Certain Carestation 620/650/650c and 750/750c Anesthesia Del
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.Class IMar 21, 2025Certain Carestation 620/650/650c and 750/750c Anesthesia Del
GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.Class IMar 21, 2025Certain Carestation 620/650/650c and 750/750c Anesthesia Del
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.Class IMar 21, 2025Certain Carestation 620/650/650c and 750/750c Anesthesia Del
GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.Class IMar 21, 2025Certain Carestation 620/650/650c and 750/750c Anesthesia Del
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.Class IMar 21, 2025Certain Carestation 620/650/650c and 750/750c Anesthesia Del
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.Class IMar 21, 2025Certain Carestation 620/650/650c and 750/750c Anesthesia Del
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)Class IISep 8, 2023There is a potential interruption of data communication betw

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