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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 4 of 4 Results
510(K) Number: K213715
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Product Description
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FDA Recall
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Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 2 05/08/2026 FEI # 2126677
GE Medical Systems, LLC
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 2 05/08/2026 FEI # 2126677
GE Medical Systems, LLC
GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed 2 03/07/2025 FEI # 2126677
GE Medical Systems, LLC
GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed 2 03/07/2025 FEI # 2126677
GE Medical Systems, LLC
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