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U.S. Department of Health and Human Services

Class 2 Device Recall DISCOVERY MR450

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 Class 2 Device Recall DISCOVERY MR450 see related information
Date Posted September 01, 2011
Recall Status1 Terminated on August 07, 2013
Recall Number Z-3123-2011
Recall Event ID 59232
510(K)Number K083147 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product GE Healthcare, Discovery MR450

Product Usage: The Discovery 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 images, parametric maps, and/or spectra, dynamic images of the structures and/ or functions 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. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery 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 00000299294MR9
00000299320MR2
00000299339MR2
00000299491MR1
00000299503MR3
00000299520MR7
00000299522MR3
00000299559MR5
00000299560MR3
00000299627MR0
00000299634MR6
00000299644MR5
00000299645MR2
00000299647MR8
00000299683MR3
00000299823MR5
00000299851MR6
00000299852MR4
00000299952MR2
00000300038MR7
00000300473MR6
00000300493MR4
00000300494MR2
00000300564MR2
00000300565MR9
00000300571MR7
00000300572MR5
00000300588MR1
00000300590MR7
00000300671MR5
00000300688MR9
00000300722MR6
00000300723MR4
00000300794MR5
00000300847MR1
00000300866MR1
00000300867MR9
00000300898MR4
00000300900MR8
00000300930MR5
00000299684MR1
00000299685MR8
00000299825MR0
00000300796MR0
00000300298MR7
00000300865MR3
00000300591MR5
00000299261MR8
00000299341MR8
00000299464MR8
00000300589MR9
00000300966MR9
00000299686MR6
00000300037MR9
00000300297MR9
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 55
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
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