GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Sig

FDA device recall Z-1207-2013 · posted 2013-05-01 · Terminated

Recall details

Recalling firm: GE Healthcare, LLC
Reason for recall: 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
Action taken: GE Healthcare sent an "Important Product Information" letter dated June 8, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers should contact their local service representative for questions regarding this notice.
Root cause: Software design
Status: Terminated
Product code: LNH
Quantity affected: 4338
Distribution: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, excluding the state of RI and the countries of Yugoslavia YEMEN Viet Nam Venezuela Uzbekistan Uruguay United Arab Emirates Tunisia
Date initiated: 2012-06-08
Date posted: 2013-05-01
Date terminated: 2014-11-03
Location: Waukesha, WI

Recalls and clearances share one API, with change alerts when new recalls post.