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U.S. Department of Health and Human Services

Class 2 Device Recall GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System

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  Class 2 Device Recall GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System see related information
Date Initiated by Firm October 01, 2007
Date Posting Updated September 16, 2008
Recall Status1 Terminated 3 on December 17, 2011
Recall Number Z-2211-2008
Recall Event ID 48683
510(K)Number K041476  
Product Classification Nuclear Magnetic Resonance Imaging System - Product Code LNH
Product GE Signa¿ Excite 1.5T MR System, GE Signa¿ Excite 3.0T MR System.
Model Numbers 5107849, 5107849-2, M3000PT, and M3000PW .


Indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.
Code Information 00000262460MR9, 00000270245MR4, 00000260692MR9, 00000269581MR5, 00000268123MR7, 00000277574MR0, 00000267973MR6, 00000280302MR1, 00000262803MR0, 00000270974MR9, 00000273229MR5, 00000277190MR5, 00000277189MR7, 00000279752MR0, 00000261198MR6, 00000272433MR4, 00000269437MR0, 00000265177MR6, 00000264407MR8, 00000265173MR5, 00000274998MR4, 00000268011MR4, 00000270383MR3, 00000262459MR1, 00000269326MR5, 00000261064MR0, 00000271248MR7, 00000263970MR6, 00000276409MR0, 00000274835MR8, 00000278722MR4, 00000271120MR8, 00000262456MR7, 00000273459MR8, 00000266821MR8, 00000266071MR0, 00000276491MR8, 00000266066MR0, 00000265061MR2, 00000266754MR1, 00000271234MR7, 00000266343MR3, 00000273365MR7, 00000262299MR1, 00000263879MR9, 00000262793MR3, 00000273341MR8, 00000266822MR6, 00000269340MR6, 00000273230MR3, 00000262800MR6, 00000261678MR7, 00000271246MR1, 00000280388MR0, 00000261205MR9, 00000262666MR1, 00000262673MR7, 00000260480MR9, 00000276591MR5, 00000279460MR0, 00000272533MR1, 00000263974MR8, 00000262667MR9, 00000261066MR5, 00000271124MR0, 00000277955MR1, 2333, 00000272072MR0, 00000261069MR9, 00000264087MR6, 00000267322MR6, 00000274839MR0, 00000265005MR9, 00000275642MR7, 00000270466MR6, 00000275086MR7, 00000261061MR6, 00000275845MR6, 00000272076MR1, 00000269435MR4, 00000270387MR4, 00000268518MR8, 00000268477MR7, 00000268515MR4, 00000269575MR7, 00000272968MR9, 00000270026MR8, 00000272969MR7, 00000272070MR4, 00000268692MR1, 00000271662MR9, 00000268417MR3, 00000270467MR4, 00000272536MR4, 00000273529MR8, 00000279146MR5, 00000275668MR, 00000260651MR5

Model No, 5107849-2

00000279077MR2, 00000282686MR5, 00000283386MR1, 00000283076MR8, 00000279423MR8, 00000278623MR4, 00000278626MR7, 00000279921MR1, 00000276633MR5, 00000273541MR3, 00000274170MR0, 00000274930MR7, 00000281703MR9, 00000281443MR2, 00000281019MR0, 00000275936MR3, 00000279713MR2, 00000273267MR5, 00000273266MR7

Model No. M3000PT

00000266842MR4, 00000266160MR1, 00000271322MR0, 00000275009MR9, 00000268302MR7, 00000263655MR3, 00000264783MR2, 00000266194MR0, 00000267528MR8, 00000026005MR8, 00000266156MR9, 00000265852MR4, 00000267533MR8, 000267533MR8ZZ, 00000265968MR8, 00000267529MR6, 00000267527MR0, 00000266690MR7, 00000264643MR8, 00000267618MR7, 00000268837MR2, 00000270528MR3, 00000270097MR9, 00000268301MR9, 00000269332MR3, 00000267860MR5

Model No. M3000PW

00000266270MR8, 00000250462MR9, 00000263921MR9

Recalling Firm/
Manufacturer
GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3894
Manufacturer Reason
for Recall
A software issue that may result in misregistration of functional and anatomical images associated with the 3.0T BrainwaveRT fMRI Application on the 3.0T Signa HDx scanner.
FDA Determined
Cause 2
Software design
Action A "GE Product Safety Notification" Customer letter addressed to Hospital Administrators, Managers of Radiology/Cardiology and Radiologists/Cardiologists dated September 14, 2007 was was sent to consignees. The letter described the safety issue, affected product, safety instructions, product correction and contact information. The letter instructed customers to scan only from the Superior to Inferior direction, when using BrainwaveRT with 2D T1 weighted scan. A GE Field Engineer site visit was also conducted to implement the correction (FMI No, 60745 & 60746), which enables users to scan in both Inferior to Superior and Superior to Inferior directions and have no mismap between the functional and anatomical images.
Quantity in Commerce 211
Distribution Worldwide Distribution --- USA including states of AL, AZ, CA, CO , CT, FL, GA ,IA , IL, IN , KY, LA, MA , MD, MI, MN, MO, MS, MT, NC, NE , NJ, NY , OH, OR, PA, PR,SD, TN, TX, UT, VA, WA, WI , and WV, the countries of Canada, Mexico, Brazil, New Zealand, Japan, Hong Kong, India, Korea, Australia, China, Italy, Lebanon, Netherlands, Norway, Russian Federation, South Africa, Turkey, Iran, Kuwait, Taiwan, Switzerland, Germany, France, Great Britain, Ireland, Denmark, Spain, Saudi Arabia, and Macau.
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 = GE MEDICAL SYSTEMS, LLC
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