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U.S. Department of Health and Human Services

Class 2 Device Recall EXCITE

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  Class 2 Device Recall EXCITE see related information
Date Initiated by Firm June 01, 2006
Date Posted May 18, 2007
Recall Status1 Terminated 3 on February 24, 2008
Recall Number Z-0815-2007
Recall Event ID 37653
510(K)Number K040444  
Product Classification Magnetic Resonance System - 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/
Manufacturer		 GE Medical Systems LLC
3200 N Grandview Blvd
Waukesha WI 53188-1693
For Additional Information Contact
262-544-3894
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		 Other
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = GENERAL ELECTRIC CO.
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