Recall Z-1209-2013 — GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System. Indicated for use as a diagnostic imaging device.
U.S. FDA — Device Enforcement · United States · 2012-06-08 · Class II
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Reported risk: GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation revers
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