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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 December 14, 2007
Date Posted September 17, 2008
Recall Status1 Terminated 3 on April 12, 2012
Recall Number Z-1891-2008
Recall Event ID 48073
510(K)Number K041476  
Product Classification Whole body magnetic resonance scanner - Product Code LNH
Product GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System The product is used 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 body.
Code Information Model : 5107849 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 00000275668MR2 and 00000260651MR5   Model 5107849-2: 00000279077MR2 00000282686MR5 00000283386MR1 00000283076MR8 00000279423MR8 00000278623MR4 00000278626MR7 00000279921MR1 00000276633MR5 00000273541MR3 00000274170MR0 00000274930MR7 00000281703MR9 00000281443MR2 00000281019MR0 00000275936MR3 00000279713MR2 00000273267MR5 and 00000273266MR7  Model: 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 and 00000267860MR5  Model: M3000PW: 00000266270MR8 00000250462MR9 and 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		 GE healthcare has become aware of an artifact which could affect the diagnostic capability associated with the 3.0T Propeller T2 Flair application of the 3.0T Signa HDx scanner.
FDA Determined
Cause 2		 Software design
Action Consignees were sent a "GE Healthcare Product Safety Notification" letter dated 9/14/07. The letter was addressed to Hospital Administrators, Managers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the safety issue, affected product, safety instructions, product correction and contact information. FMI 60745 and 60746 was communicated directly to the GE Healthcare service engineers who provide the modification at the customer site. For assistance, contact GE Healthcare at 1-262-544-3894.
Quantity in Commerce 147
Distribution AL, CA, CO,CT, AZ, FL, GA, LA, MS, MT, IA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NY, NV, OH, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PUERTO RICO. AUSTRALIA, CHINA, HONG KONG, INDIA, JAPAN, SOUTH KOREA, NEW ZEALAND, TAIWAN, SWITZERLAND, GERMANY, DENMARK, SPAIN, FRANCE, GREAT BRITAIN, IRELAND, IRAN, ITALY, KUWAIT, LEBANON, NETHERLANDS, NORWAY, RUSSIA, SAUDI ARABIA, TURKEY, SOUTH AFRICA, BRAZIL, CANADA, and MEXICO.
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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