FDA (Devices) recall action 64918
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
GE Healthcare is recalling 4,338 MRI systems because axial and coronal images from certain sagittal 3D series may display a left-to-right flip.
GE Healthcare is recalling specific MRI systems because reformatted images may display a left-to-right flip, potentially affecting diagnostic accuracy.
GE Healthcare is recalling 822 GE 1.5T SIGNA HDe MR systems worldwide due to a software issue that may cause left-to-right image flips in specific reformatted views.