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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 6 of 6 Results
510(K) Number: K131576
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Revolution EVO, Optima CT660, Optima CT680 CT Systems. 2 06/25/2021 FEI # 2126677
GE Healthcare, LLC
Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; ... 2 07/31/2018 FEI # 2126677
GE Healthcare, LLC
GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended fo... 2 08/17/2018 FEI # 3002808529
GE Healthcare Japan Corporation
GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system 2 12/04/2024 FEI # 3008284470
GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution EVO X-ray system 2 06/12/2017 FEI # 2126677
GE Healthcare, LLC
GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular X-r... 2 08/17/2018 FEI # 3002808529
GE Healthcare Japan Corporation
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