• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Optima MR450w

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Optima MR450w see related information
Date Posted September 01, 2011
Recall Status1 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
262-513-4122
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 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 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
-
-