GE Medical Systems LLC GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System
Brand
GE Medical Systems LLC
Lot Codes / Batch Numbers
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
Products Sold
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
GE Medical Systems LLC is recalling GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System due to 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 eig. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The corrective action is already completed and all customers have been notified via a personal visit to each site, to install a software patch beginning June, 2006.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026