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Terminated

GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device.

FDA Recall Z-1207-2013 · Posted 2013-05-01

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2012-06-08
Date Terminated2014-11-03
Product Quantity4338

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

Firm Action

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

Distribution Pattern

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 Thailand Tanzania Taiwan Turkey Syria Switzerland Sweden Spain South Korea South Africa Slovenia Slovakia Singapore Saudi Arabia Russia Romania Reunion Qatar Portugal Poland Philippines Peru Pakistan Paraguay Philippines Oman Norway Nigeria New Zealand Netherlands Morocco Mexico Martinique Malaysia Macedonia Mauritania Luxembourg Lithuania Libya Lebanon Latvia Kuwait Kenya Korea Korea (Republic Of [South] Korea) KUWAIT Kazakhstan Jordan Japan Jamaica Italy Israel Ireland Iran Iraq Indonesia India Hungary Hong Kong Honduras Guadeloupe Greece Germany Georgia, Republic of French Polynesia France Finland Estonia Ecuador Egypt Denmark Dominican Republic Czech Republic Croatia Colombia China Chile Canada Bulgaria Brazil Bosnia And Herzegovina Belgium Belarus Barbados Bahrain Austria Australia Argentina Arab Emirates Algeria and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091536OPTIMA MR450WGe Medical Systems, LLC · 2009-07-17K083147DISCOVERY MR450Ge Medical Systems, LLC · 2008-11-04K081028SIGNA 3.0T MR750 SYSTEMGe Medical Systems, LLC · 2008-04-25K052293GE 1.5T AND 3.0T SIGNA HDX MR SYSTEMGe Medical Systems, LLC · 2005-09-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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