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U.S. Department of Health and Human Services

Class 2 Device Recall EXCITE

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 Class 2 Recall
see related information
Date Posted May 18, 2007
Recall Status1 Terminated on February 24, 2008
Recall Number Z-0815-2007
Recall Event ID 37653
Premarket Notification
510(K) Number
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System
Code Information 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/
GE Medical Systems LLC
3200 N Grandview Blvd
Waukesha, Wisconsin 53188-1693
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Software Design
Action 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.
Quantity in Commerce 30 units
Distribution Worldwide, including USA, China, Finland, Germany, Israel, Italy, Korea, Spain, and Taiwan.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = GENERAL ELECTRIC CO.