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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 Initiated by Firm October 01, 2007
Date Posting Updated September 16, 2008
Recall Status1 Terminated 3 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/
GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
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 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