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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: K163213
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Product Description
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FDA Recall
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GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed 2 03/07/2025 FEI # 2126677
GE Medical Systems, LLC
GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed 2 03/07/2025 FEI # 2126677
GE Medical Systems, LLC
Revolution Apex, Revolution CT with Apex Edition 2 04/05/2022 FEI # 2126677
GE Healthcare, LLC
Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT w... 2 11/24/2021 FEI # 2126677
GE Healthcare, LLC
The system is intended to produce cross-sectional images of the body by computer reconstruction of x... 2 07/08/2021 FEI # 2126677
GE Healthcare, LLC
System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition 2 02/17/2021 FEI # 2126677
GE Healthcare, LLC
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