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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 Posted September 16, 2008
Recall Status1 Terminated 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
262-544-3894
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 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 = GE MEDICAL SYSTEMS, LLC
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