Company: GE Healthcare LLC
Date of Enforcement Report: 5/8/2013
Class ll:
PRODUCT
GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device. Recall Number Z-1208-2013
REASON
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 reversed. This issue may lead to incorrect localization of findings, particularly where symmetric anatomy is present.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on 6/8/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
822
DISTRIBUTION
Nationwide and Internationally
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