May

2013

GE 1.5T SIGNA HDe MR SYSTEM Cl ll GE Healthcare

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

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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GE 1.5T SIGNA HDe MR SYSTEM Cl ll GE Healthcare

Amy Sellers

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