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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 SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System 2 07/12/2021 GE Healthcare, LLC
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system 2 10/16/2021 GE Healthcare, 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
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
5) Signa HDx (K052293 Signa HDx and HDxt MR Systems) Signa HDx or Signa HDxt (K052293 Signa ... 2 02/24/2011 GE Healthcare, LLC
GE 1.5T and 3.0T Signa HDX MR System Model Number(s): 2226300, 2377062-61, 2395001, 2395001-2, 510... 2 09/11/2008 GE Healthcare
GE 1.5T and 3.0T Signa HDx MR System The product is used as a diagnostic imaging device to produce... 2 09/17/2008 GE Healthcare
GE 1.5T and 3.0T Signa® HDx MR System Model Numbers: 5127452, 2377062-61, and 2395001-2. Indica... 2 09/16/2008 GE Healthcare
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
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
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