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U.S. Department of Health and Human Services

Class 2 Device Recall GE 1.5T and 3.0T Signa HDx MR System

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 Class 2 Device Recall GE 1.5T and 3.0T Signa HDx MR System see related information
Date Posted September 16, 2008
Recall Status1 Terminated on December 17, 2011
Recall Number Z-2210-2008
Recall Event ID 48683
510(K)Number K052293 
Product Classification Nuclear Magnetic Resonance Imaging System - Product Code LNH
Product GE 1.5T and 3.0T Signa¿ HDx MR System
Model Numbers: 5127452, 2377062-61, and 2395001-2.

Indicated for use 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 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.
Code Information 00000HDMR20228
00000276057MR7
00000275160MR0
000000HDMR2544
00000HDMR10417
00000HDMR10094
00000274383MR9
00000273832MR6
00000274385MR4
00000276073MR4
00000274359MR9
00000HDMR10273
00000273119MR8
00000DDDM10670
00000HDMR20073
00000HDMR10739
000000HDMR2451
000000HDMR2335
00000HDMR20189
000000HDMR1004
00000HDMR10489
00000HDMR10291
00000HDMR20151
00000HDMR20061
00000HDMR10743
000000HDMR2528
000000HDMR2976
00000HDMR20044
000000HDMR2773
00000HDMR20294
00000HDMR20059
00000HDMR10418
00000HDMR10831
00000HDMR20036
00000HDMR20056


Model No. 2377062-61

00000008376YR6
00000007126YR6
00000007551YR5
00000007555YR6
00000006690YR2
00000007518YR4
00000008525YR8
00000005222YR5
00000007134YR0
00000008354YR3
00000005989YR9
00000007107YR6
00000008100YR0
00000007594YR5
00000006710YR8
00000008103YR4
00000007092YR0
00000007503YR6
00000007574YR7
00000006754YR6
00000007542YR4
00000008116YR6
00000008522YR5
00000006685YR2
00000007105YR0
00000008564YR7
00000005974YR1
00000005545YR9
00000006705YR8
00000006600YR1
00000007585YR3
00000005532YR7
00000008549YR8
00000007533YR3
00000007498YR9
00000005231YR6
00000006583YR9
00000005216YR7
00000007554YR9
00000009031YR6
00000006708YR2
00000007117YR5
00000007864YR2
00000007866YR7
00000007514YR3
00000008342YR8
00000005546YR7
00000007892YR3
00000007865YR9
00000006556YR5
00000006660YR5
00000007862YR6
00000009421YR9
00000007556YR4
00000008378YR2
00000008539YR9
00000006656YR3
00000005536YR8
00000008115YR8
00000008335YR2
00000052299YR0
00000006727YR2
00000006726YR4
00000007572YR1

Model No, 2395001-2

00000280673MR5
00000278397MR5
00000277211MR9
00000276434MR8
00000275968MR6
00000278549MR1
00000280781MR6
00000276265MR6
00000275046MR1
00000283745MR8
00000284233MR4
00000275648MR4
00000280000MR1
00000279068MR1
00000275967MR8
00000274744MR2
00000276266MR4
00000280001MR9
00000278851MR1
00000275647MR6
00000281340MR0
00000275465MR3
00000282549MR5

Recalling Firm/
Manufacturer
GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3894
Manufacturer Reason
for Recall
A software issue that may result in misregistration of functional and anatomical images associated with the 3.0T BrainwaveRT fMRI Application on the 3.0T Signa HDx scanner.
FDA Determined
Cause 2
Software design
Action A "GE Product Safety Notification" Customer letter addressed to Hospital Administrators, Managers of Radiology/Cardiology and Radiologists/Cardiologists dated September 14, 2007 was was sent to consignees. The letter described the safety issue, affected product, safety instructions, product correction and contact information. The letter instructed customers to scan only from the Superior to Inferior direction, when using BrainwaveRT with 2D T1 weighted scan. A GE Field Engineer site visit was also conducted to implement the correction (FMI No, 60745 & 60746), which enables users to scan in both Inferior to Superior and Superior to Inferior directions and have no mismap between the functional and anatomical images.
Quantity in Commerce 58
Distribution Worldwide Distribution --- USA including states of AL, AZ, CA, CO , CT, FL, GA ,IA , IL, IN , KY, LA, MA , MD, MI, MN, MO, MS, MT, NC, NE , NJ, NY , OH, OR, PA, PR,SD, TN, TX, UT, VA, WA, WI , and WV, the countries of Canada, Mexico, Brazil, New Zealand, Japan, Hong Kong, India, Korea, Australia, China, Italy, Lebanon, Netherlands, Norway, Russian Federation, South Africa, Turkey, Iran, Kuwait, Taiwan, Switzerland, Germany, France, Great Britain, Ireland, Denmark, Spain, Saudi Arabia, and Macau.
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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