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GE Medical Systems China Co., Ltd.

22 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855 recall (Z-2306-2026)GE Medical Systems China Co., Ltd.2026-06-03
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 6 recall (Z-0913-2026)GE Medical Systems China Co., Ltd.2025-12-18
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 7 recall (Z-0914-2026)GE Medical Systems China Co., Ltd.2025-12-18
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable recall (Z-0915-2026)GE Medical Systems China Co., Ltd.2025-12-18
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultra recall (Z-2029-2025)GE Medical Systems China Co., Ltd.2025-06-26
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog recall (Z-2030-2025)GE Medical Systems China Co., Ltd.2025-06-26
GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems recall (Z-1624-2025)GE Medical Systems China Co., Ltd.2025-04-29
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system. recall (Z-1625-2025)GE Medical Systems China Co., Ltd.2025-04-29
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system. recall (Z-1626-2025)GE Medical Systems China Co., Ltd.2025-04-29
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system. recall (Z-1627-2025)GE Medical Systems China Co., Ltd.2025-04-29
GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system. recall (Z-1628-2025)GE Medical Systems China Co., Ltd.2025-04-29
GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system. recall (Z-1629-2025)GE Medical Systems China Co., Ltd.2025-04-29
GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system. recall (Z-1630-2025)GE Medical Systems China Co., Ltd.2025-04-29
GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system. recall (Z-1631-2025)GE Medical Systems China Co., Ltd.2025-04-29
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system. recall (Z-1632-2025)GE Medical Systems China Co., Ltd.2025-04-29
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system. recall (Z-1633-2025)GE Medical Systems China Co., Ltd.2025-04-29
GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system. recall (Z-1634-2025)GE Medical Systems China Co., Ltd.2025-04-29
GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system. recall (Z-1635-2025)GE Medical Systems China Co., Ltd.2025-04-29
GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system. recall (Z-1636-2025)GE Medical Systems China Co., Ltd.2025-04-29
GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system. recall (Z-1637-2025)GE Medical Systems China Co., Ltd.2025-04-29
GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system. recall (Z-1638-2025)GE Medical Systems China Co., Ltd.2025-04-29
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) recall (Z-2656-2023)GE Medical Systems China Co., Ltd.2023-09-29

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Every clearance here is in the API, with alerts when new ones post.