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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 11 Results
510(K) Number: K081028
 
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Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a whole body... 2 08/02/2017 GE Medical Systems, LLC
GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2. 2 12/28/2015 GE Medical Systems, LLC
GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM o... 2 05/01/2014 GE Healthcare, LLC
GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w... 2 04/21/2014 GE Healthcare, LLC
GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner desig... 2 09/27/2013 GE Healthcare, LLC
GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2... 2 09/23/2013 GE Healthcare, LLC
GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa ... 2 05/01/2013 GE Healthcare, LLC
Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, an... 2 03/11/2013 GE Healthcare, LLC
GE Healthcare, 3.0T Signa MR750 (Marketing Name: GE Discovery MR750) Product Usage: The GE Sigma... 2 09/01/2011 GE Healthcare, LLC
GE Healthcare Discovery MR750 3.0T The GE Signa® MR750 System is a whole body magnetic resonance sc... 2 02/18/2011 GE Healthcare, LLC
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