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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 Posted 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/
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 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
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