Class 2 Device Recall Optima MR450w

• Date Initiated by Firm: July 29, 2011
• Date Posted: September 01, 2011
• Recall Status: Terminated on August 07, 2013
• Recall Number: Z-3121-2011
• Recall Event ID: 59232
• 510(K)Number: K091536
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: GE Healthcare, 1.5T Optima MR450w; ; Product Usage: The Optima MR450w 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 data, parametric maps, or dynamic images of the structures or functions of the entire body. The indication for use includes, but is not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Optima MR450w 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: 00000298836MR8 00000298869MR9 00000029854MR5 00000295134MR1 00000296070MR6 00000296097MR9 00000296171MR2 00000296300MR7 00000296418MR7 00000296462MR5 00000296469MR0 00000296595MR2 00000296626MR5 00000296829MR5 00000296840MR2 00000296841MR0 00000296860MR0 00000296888MR1 00000296894MR9 00000297133MR1 00000297134MR9 00000297147MR1 00000297355MR0 00000297387MR3 00000297493MR9 00000297833MR6 00000297891MR4 00000298050MR6 00000298083MR7 00000298114MR0 00000298247MR8 00000298248MR6 00000298249MR4 00000298334MR4 00000298386MR4 00000298387MR2 00000298494MR6 00000298512MR5 00000298535MR6 00000298552MR1 00000298573MR7 00000298655MR2 00000298656MR0 00000298834MR3 00000298861MR6 00000298870MR7 00000298889MR7 00000298907MR7 00000298932MR5 00000298943MR2 00000298959MR8 00000298960MR6 00000299141MR2 00000299160MR2 00000299161MR0 00000299171MR9 00000299172MR7 00000299173MR5 00000299199MR0 00000299200MR6 00000299230MR3 000005148810-3 00000300296MR1 00000300724MR2 00000300883MR6 00000300906MR5 00000300929MR7 00000300967MR7 00000300968MR5 00000300985MR9 00000301013MR9 00000301095MR6 00000297132MR3 00000298493MR8 00000296321MR3 00000293642MR5 00000299340MR0 00000297386MR5 00000297422MR8 00000298944MR0 00000296547MR3 00000297154MR7 00000299140MR4 00000297007MR7 00000298272MR6 00000296834MR5 00000297155MR4 00000298676MR8 00000297701MR5 00000296879MR0 00000297468MR1 00000297494MR7 00000297636MR3 00000298073MR8 00000298242MR9 00000298385MR6 00000298430MR0 00000298567MR9 00000298850MR9 00000298431MR8 00000297850MR0 00000298717MR0 00000300986MR7 00000297156MR2 00000298473MR0 00000300472MR8 00000300586MR5 00000299229MR5 00000294098MR9 00000294280MR3 00000294494MR0 00000294643MR2 00000294913MR9 00000295092MR1 00000295241MR4 00000296096MR1 00000296307MR2 00000296429MR4 00000296573MR9 00000297006MR9 00000297877MR3 00000298399MR7 00000298908MR5 00000292973MR5 00000293206MR9 00000293724MR1 00000294967MR5 00000295709MR0 00000296514MR3 00000298041MR5 00000293000MR6 00000293920MR5 00000296493MR0 00000295830MR4 00000293603MR7 00000298211MR4 00000296820MR4 00000297807MR0 00000294771MR1 00000298332MR8 00000298665MR1 00000292928MR9 00000293327MR3 00000293919MR7 00000294575MR6 00000295847MR8 00000296032MR6 00000296499MR7 00000296814MR7 00000297164MR6 00000297715MR5 00000298734MR5 00000294397MR5 00000294548MR3 00000297813MR8 00000294119MR3 00000294601MR0 00000295023MR6 00000294451MR0
• 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: 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: 159
• 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