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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 15 Results
510(K) Number: K041476
 
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1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System 2 04/04/2022 GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Ex... 2 02/09/2022 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
MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa® 3.0T o... 2 07/23/2018 GE Medical Systems, LLC
GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole bo... 2 11/10/2015 GE Healthcare
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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