Company:GE Healthcare-Americas Signa 3.0T EXCITE
Date of Enforcement Report:5/23/2007
Class:ll

PRODUCT
GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance system, Recall # Z-0815-2007

REASON
To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included in the software.

CODE
00000249264MR3, 00000257756MR7, 00000255196MR8, 00000246630MR8, 00000259107MR1, 00000248178MR6, 00000257451MR5, 00000256200MR7, 00000260871MR9, 00000252451MR0, 00000259108MR9, 00000254480MR7, 00000254482MR3, 00000256198MR3, 00000249263MR5, 00000250755MR6, 00000251090MR7, 00000GE0131001, 00000GE0213040, 00000254375MR9, 00000GE0205028, 00000GE0210034, 00000227995MR8, 00000GE0212037, 00000GE0226049, 00000GE0410083, 00000260871MR9, 00000GE0234057, 00000GE0123041, 00000GE0302068

RECALLING FIRM/MANUFACTURER
GE Medical Systems LLC, Waukesha, WI, by visit beginning June, 2006. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
30 units

DISTRIBUTION
Nationwide and Internationally