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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 9 of 9 Results
510(K) Number: K012200
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Signa 1.5T TwinSpeed Magnetic Resonance Imaging System 2 04/04/2022 GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR Syste... 2 02/09/2022 GE Healthcare, LLC
Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance ... 2 01/07/2019 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
GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed... 2 08/05/2015 GE Healthcare
GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGN... 2 03/20/2015 GE Healthcare
This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR4... 1 02/18/2015 GE Healthcare
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