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GE Healthcare (China) Co., Ltd.

24 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
SIGNA Creator, SIGNA Explorer, NMRI systems recall (Z-1239-2025)GE Healthcare (China) Co., Ltd.2025-02-28
Brivo MR355, NMRI system recall (Z-1240-2025)GE Healthcare (China) Co., Ltd.2025-02-28
Optima MR360, NMRI system recall (Z-1241-2025)GE Healthcare (China) Co., Ltd.2025-02-28
SIGNA MR355, SIGNA MR360, NMRI system recall (Z-1242-2025)GE Healthcare (China) Co., Ltd.2025-02-28
SIGNA MR380, NMRI system, Non-US Only recall (Z-1243-2025)GE Healthcare (China) Co., Ltd.2025-02-28
GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems lab recall (Z-0600-2025)GE Healthcare (China) Co., Ltd.2024-12-04
GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems recall (Z-0601-2025)GE Healthcare (China) Co., Ltd.2024-12-04
GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system recall (Z-0602-2025)GE Healthcare (China) Co., Ltd.2024-12-04
GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems recall (Z-0603-2025)GE Healthcare (China) Co., Ltd.2024-12-04
GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems recall (Z-0604-2025)GE Healthcare (China) Co., Ltd.2024-12-04
GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography syste recall (Z-0605-2025)GE Healthcare (China) Co., Ltd.2024-12-04
GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography recall (Z-0606-2025)GE Healthcare (China) Co., Ltd.2024-12-04
GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system recall (Z-0607-2025)GE Healthcare (China) Co., Ltd.2024-12-04
GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system recall (Z-0608-2025)GE Healthcare (China) Co., Ltd.2024-12-04
GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/comput recall (Z-0609-2025)GE Healthcare (China) Co., Ltd.2024-12-04
GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200 recall (Z-0610-2025)GE Healthcare (China) Co., Ltd.2024-12-04
GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography syst recall (Z-0611-2025)GE Healthcare (China) Co., Ltd.2024-12-04
GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomograph recall (Z-0612-2025)GE Healthcare (China) Co., Ltd.2024-12-04
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refr recall (Z-0613-2025)GE Healthcare (China) Co., Ltd.2024-12-04
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operato recall (Z-0614-2025)GE Healthcare (China) Co., Ltd.2024-12-04
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: recall (Z-0615-2025)GE Healthcare (China) Co., Ltd.2024-12-04
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: recall (Z-0616-2025)GE Healthcare (China) Co., Ltd.2024-12-04
GE Proteus XR/A radiographic system recall (Z-0550-2025)GE Healthcare (China) Co., Ltd.2024-11-25
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) recall (Z-2733-2024)GE Healthcare (China) Co., Ltd.2024-08-26

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