Recall Z-1208-2013— GE Healthcare, LLC

Name: FDA recall Z-1208-2013
Creator: U.S. Food and Drug Administration
Published: 2012-06-08

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2012-06-08, terminated 2014-11-03. It names one FDA 510(k) clearance: K052978. Product: GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.. 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 revers.

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2012-06-08
Terminated: 2014-11-03
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K052978 — GE 1.5T SIGNA HDE MR SYSTEMGe Medical Systems, LLC·cleared 2005-11-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.