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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: K053009
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FDA Recall
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Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance ... 2 01/07/2019 GE Healthcare, LLC
GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa P... 2 05/01/2013 GE Healthcare, LLC
GE Healthcare Signa Ovation 0.35T, Model Numbers: Ovation 1-3 (2276937), Ovation 4 (2377062-2, 2377... 2 08/25/2009 GE Medical Systems, LLC
GE Signa Ovation 0.35 T MR System. The Signa Ovation System is an open, whole body scanner design... 2 06/30/2009 GE Medical Systems, LLC