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U.S. Department of Health and Human Services

Class 2 Device Recall SIGNA 3.0T MR750 SYSTEM

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  Class 2 Device Recall SIGNA 3.0T MR750 SYSTEM see related information
Date Initiated by Firm July 29, 2011
Date Posted September 01, 2011
Recall Status1 Terminated 3 on August 07, 2013
Recall Number Z-3122-2011
Recall Event ID 59232
510(K)Number K081028  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product GE Healthcare, 3.0T Signa MR750 (Marketing Name: GE Discovery MR750)

Product Usage: The GE Sigma MR750 System is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic images, parametric maps, and/or dynamic images of the 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. The images produced by the GE Sigma MR750 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and spectra, when interpreted by a trained physician yield information that may assist in diagnosis.
Code Information 00000299182MR6 00000029060MR5 00000288408MR8 00000288907MR9 00000289309MR7 00000289310MR5 00000289961MR5 00000290050MR4 00000290137MR9 00000290202MR1 00000290457MR1 00000290502MR4 00000290636MR0 00000290659MR2 00000290704MR6 00000290773MR1 00000290957MR0 00000291185MR7 00000291244MR2 00000291325MR9 00000291363MR0 00000291397MR8 00000291464MR6 00000291489MR3 00000291877MR9 00000291980MR1 00000292367MR0 00000292431MR4 00000292471MR0 00000292528MR7 00000292634MR3 00000292678MR0 00000292843MR0 00000293015MR4 00000293261MR4 00000293338MR0 00000293561MR7 00000293646MR6 00000293874MR4 00000293918MR9 00000294018MR7 00000294057MR5 00000294472MR6 00000294556MR6 00000294665MR5 00000294698MR6 00000294718MR2 00000294953MR5 00000294999MR8 00000295024MR4 00000295111MR9 00000295112MR7 00000295215MR8 00000295228MR1 00000295506MR0 00000295802MR3 00000295904MR7 00000296014MR4 00000296046MR6 00000296114MR2 00000296461MR7 00000296512MR7 00000296517MR6 00000296602MR6 00000296640MR6 00000296821MR2 00000296908MR7 00000297374MR1 00000297469MR9 00000297624MR9 00000297974MR8 00000298283MR3 00000298474MR8 00000298537MR2 00000298580MR2 00000298591MR9 00000298677MR6 00000298738MR6 00000298981MR2 00000299181MR8 00000299213MR9 00000299250MR1 00000299291MR5 00000299321MR0 00000299329MR3 00000299331MR9 00000299406MR9 00000299515MR7 00000299544MR7 00000299908MR4 00000299966MR2 00000300713MR5 00000300792MR9 00000298501MR8 00000290456MR3 00000290545MR3 00000291274MR9 00000294332MR2 00000298102MR5 00000300712MR7 00000294308MR2 00000294986MR5 00000298063MR9 00000300501MR4 00000297175MR2 00000299292MR3 00000291675MR7 00000293521MR1 00000295538MR3 00000295710MR8 00000298674MR3 00000293984MR1 00000299965MR4 00000298331MR0 00000299419MR2 00000300733MR3 00000296622MR4 00000288409MR6 00000292216MR9 00000294156MR5 00000299854MR0 00000294943MR6 00000295180MR4 00000296560MR6 00000298566MR1 00000299147MR9 00000299293MR1 00000299330MR1 00000299455MR6 00000299545MR4 00000300791MR1 00000291184MR0 00000291345MR7 00000293613MR6 00000294545MR9 00000295757MR9 00000299454MR9 00000291778MR9 00000288909MR5 00000300561MR8 00000293710MR0 00000288156MR3 00000292292MR0 00000293440MR4 00000295131MR7 00000296406MR2 00000290985MR1 00000292844MR8 00000293042MR8 00000296141MR5 00000296227MR2 00000296332MR0 00000297861MR7 00000294713MR3 00000295827MR0 00000296291MR8 00000298847MR5 00000300767MR1 00000291008MR1 00000291154MR3 00000296200MR9 00000298951MR5 00000299547MR0 00000300711MR9 00000295060MR8 00000297898MR9 00000291429MR9 00000293438MR8 00000295521MR9 00000297157MR0 00000298246MR0 
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall		 GE Healthcare has become aware of two potential safety issues associated with MR products (Optima MR450w, Discovery MR450, Discovery MR750, Brivo MR355, Optima MR360) that may impact patient safety. 1) Inline post-processed (i.e. automated post-processing) image locations are not correctly annotated under some conditions. 2) Reference images displayed in Functool FiberTrak do not match with
FDA Determined
Cause 2		 Software design
Action GE Healthcare sent an "Urgent Medical Device Correction" letter dated July 27, 2011 to customers with affected systems. The letter described the recalled product, safety issues and recommended actions to be taken. The letter provided immediate mitigation (Safety Instuctions) that address each issue. The letter states that the recalling firm will contact customers to arrange to provide a software upgrade to all affected systems at no cost. For any questions concerning this notification contact your local service representative.
Quantity in Commerce 171
Distribution Worldwide Distribution - USA (nationwide) including the states of: AL, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, LA,ME, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WT, WY. and the countries of: AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CROAT IA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KUWAIT, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, REPUBLIC OF KOREA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUKEYand UNITED KINGDOM.
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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