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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 10 Results
Related Medical Device Recalls Date Classified to: 03/30/2014
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Z-1424-2011 - 1) Signa Lx ( K962061 Signa Horizon Cx) The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, saggital, coronal and oblique images of... 2 Feb-24-2011 GE Healthcare, LLC
Z-1425-2011 - 2) Signa Advantage SP (K942604 Signa Advantage SP MR System) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution ... 2 Feb-24-2011 GE Healthcare, LLC
Z-1426-2011 - 3) Signa Advantage (K911959 Signa Advantage MR System) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and... 2 Feb-24-2011 GE Healthcare, LLC
Z-1427-2011 - 4) Signa HDe (K052978 GE 1.5T Signa HDe MR System) The GE Signa® HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and sho... 2 Feb-24-2011 GE Healthcare, LLC
Z-1433-2011 - 10) Brivo MR355/Optima MR360 Not yet 510(K) cleared and are not distributed in the US. (K103330) The Brivo MR355/ Optima MR360 is a whole body magnetic resonance scanner designed to support high r... 2 Feb-24-2011 GE Healthcare, LLC
Z-1429-2011 - 6) Signa Excite (K041476 Signa Excite 1.5T and 3.0T) Signa Excite, 12x (K041476 Signa Excite 1.5T and 3.0T) The GE Signa® HDe MR system is a whole body magnetic resonance scanner designed to suppo... 2 Feb-24-2011 GE Healthcare, LLC
Z-1430-2011 - 7) Signa OpenSpeed (K032795 GE 0.7T Signa OpenSpeed with EXCITE MR System) The 0.7T Signa Openspeed with Excite Magnetic Resonance System is an open, whole body scanner designed to suppo... 2 Feb-24-2011 GE Healthcare, LLC
Z-1431-2011 - 8) Signa 3.0T Infinity with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) Signa 3.0T with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System) Th... 2 Feb-24-2011 GE Healthcare, LLC
Z-1432-2011 - 9) Signa Excite 1.5 T (Excite II) (K013636 Signa Infinity MR System with EXCITE Technology) Signa Infinity MR System with EXCITE (K013636 Signa Infinity MR System with EXCITE Technology) ... 2 Feb-24-2011 GE Healthcare, LLC
Z-1428-2011 - 5) Signa HDx (K052293 Signa HDx and HDxt MR Systems) Signa HDx or Signa HDxt (K052293 Signa HDx and HDxt MR Systems) Signa HDxt (K052293 Signa HDx and HDxt MR Systems ) The GE Sign... 2 Feb-24-2011 GE Healthcare, LLC
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