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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 December 14, 2007
Date Posting Updated September 17, 2008
Recall Status1 Terminated 3 on April 12, 2012
Recall Number Z-1890-2008
Recall Event ID 48073
510(K)Number K052293  
Product Classification Whole body magnetic resonance scanner - Product Code LNH
Product GE 1.5T and 3.0T Signa HDx MR System The product is used 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 body.
Code Information Model 5127452:

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 and, 00000HDMR20056

Model 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 and, 00000007572YR1

Model 2395001-2

00000280673MR5, 00000278397MR5, 00000277211MR9, 00000276434MR8, 00000275968MR6, 00000278549MR1, 00000280781MR6, 00000276265MR6, 00000275046MR1, 00000283745MR8, 00000284233MR4, 00000275648MR4, 00000280000MR1, 00000279068MR1, 00000275967MR8, 00000274744MR2, 00000276266MR4, 00000280001MR9, 00000278851MR1, 00000275647MR6, 00000281340MR0, 00000275465MR3 and, 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
GE healthcare has become aware of an artifact which could affect the diagnostic capability associated with the 3.0T Propeller T2 Flair application of the 3.0T Signa HDx scanner.
FDA Determined
Cause 2
Software design
Action Consignees were sent a "GE Healthcare Product Safety Notification" letter dated 9/14/07. The letter was addressed to Hospital Administrators, Managers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the safety issue, affected product, safety instructions, product correction and contact information. FMI 60745 and 60746 was communicated directly to the GE Healthcare service engineers who provide the modification at the customer site. For assistance, contact GE Healthcare at 1-262-544-3894.
Quantity in Commerce 122
Distribution AL, CA, CO,CT, AZ, FL, GA, LA, MS, MT, IA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NY, NV, OH, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PUERTO RICO. AUSTRALIA, CHINA, HONG KONG, INDIA, JAPAN, SOUTH KOREA, NEW ZEALAND, TAIWAN, SWITZERLAND, GERMANY, DENMARK, SPAIN, FRANCE, GREAT BRITAIN, IRELAND, IRAN, ITALY, KUWAIT, LEBANON, NETHERLANDS, NORWAY, RUSSIA, SAUDI ARABIA, TURKEY, SOUTH AFRICA, BRAZIL, CANADA, and MEXICO.
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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