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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 9 of 9 Results
Related Medical Device Recalls
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Z-3021-2017 - Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan tim... 2 08/02/2017 GE Medical Systems, LLC
Z-3022-2017 - Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan ... 2 08/02/2017 GE Medical Systems, LLC
Z-3023-2017 - Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to noise ratio, and short scan times. It ... 2 08/02/2017 GE Medical Systems, LLC
Z-3024-2017 - Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It... 2 08/02/2017 GE Medical Systems, LLC
Z-3029-2017 - Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registrati... 2 08/02/2017 GE Medical Systems, LLC
Z-3026-2017 - SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and ... 2 08/02/2017 GE Medical Systems, LLC
Z-3027-2017 - 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa® HDx MR system is a whole body magnetic resonance scanner designed to support... 2 08/02/2017 GE Medical Systems, LLC
Z-3028-2017 - 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high ... 2 08/02/2017 GE Medical Systems, LLC
Z-3025-2017 - Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and sho... 2 08/02/2017 GE Medical Systems, LLC
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