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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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Product Description
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FDA Recall
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Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and... 2 01/11/2010 GE Medical Systems, 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
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SY... 2 08/09/2013 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, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx fami... 2 11/10/2015 GE Healthcare
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
GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa ... 2 05/01/2013 GE Healthcare, 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
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 11.x, sold under the following product names: 1.5T C... 2 10/15/2018 GE Medical Systems, LLC
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