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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 19 Results
510(K) Number: K052293
 
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1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance I... 2 04/04/2022 GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA ... 2 02/09/2022 GE Healthcare, LLC
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system 2 10/16/2021 GE Healthcare, LLC
1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System 2 07/12/2021 GE Healthcare, LLC
SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi ... 2 01/28/2020 GE Healthcare, LLC
GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T C... 2 10/15/2018 GE Medical Systems, LLC
GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA... 2 10/15/2018 GE Medical Systems, LLC
GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: ... 2 10/15/2018 GE Medical Systems, LLC
1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Produc... 2 08/02/2017 GE Medical Systems, LLC
GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic re... 2 11/10/2015 GE Healthcare
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