Events

Recall of Device Recall GE Healthcare, SIGNA HDxt 3.0T

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72301
  • Event Risk Class
    Class 2
  • Event Number
    Z-0259-2016
  • Event Initiated Date
    2015-08-31
  • Event Date Posted
    2015-11-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140635
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Reason
    When performing head or neck scans, the currently displayed sar values could be lower than the actual sar in the head as predicted by sar modeling. the predicted head sar value from the modeling suggests the actual sar in the head could exceed iec60601-2-33 limit of 3.2 w/kg for some scans.
  • Action
    GE Healthcare sent an Urgent Medical Device Correction letter dated August 31, 2015. The letter was addressed to Hospital Administrators/Risk Managers, Radiology Department Managers, & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall GE Healthcare, SIGNA HDxt 3.0T
  • Model / Serial
    00000275183MR1 609652MR3T 00000848BD5339 2145903TXMRE5 000000HDMR3480 MR98508 000000HDMR5861 865545MR3T 002004-0513-07 617754MR4 002004-0701-18 3137453TMR 000000HDMR2370 NYP347652 002004-0701-15 713704HMR4 000000HDMR3070 517353VH3 00000HDMR20151 313294MR 002004-0917-18 617754MR5 002004-0930-12 615TANMR 002005-0114-20 614722MR3 002005-0127-08 513451MR2 000000000R4044 661CBCCMR 000000HDMR4161 203863MR3T 000000HDMR3916 313593MR3T 002005-0328-17 2709263HD 00000HDMR20114 419383MR3T 000000HDMR2328 7067213TMR 00000930BD5D54 801588MR2 002004-0520-04 615777MR3T 000000HDMR1169 LONGWOOD30MR2 000000HDMR3396 3096653TMR 000000HDMR2818 402552NMC2 000000HDMR2952 415600D3T 00000266754MR1 423844MR2 000000HDMR2721 212305MR83T 000000HDMR3624 RADNETMR1521 00000011015YR5 928317MR1 000000HDMR2854 619543MR2 000000HDMR2481 703478MR5 0948BD61FA 509758TMR 00000275288MR9 831423MR 000000HDMR5864 480425MR5 00000274078MR5 510MIA3T 0000006-0425-3 610433MR 002005-1212-15 602406MR6 00000274744MR2 M48823 00000274745MR9 573815BMR1 000000HDMR5241 406751K3T 00000279999MR7 703573MR5 00000281442MR4 928213MR3T 00000282733MR5 504MCLMR 00000284262MR3 865481MR3T 00000284235MR9 612626MR3T #N/A 269342MR3TCH2 00000285497MR4 517374MR3T 002004-0416-18 415353UMR9 002005-0316-09 850656TD3T 00000282373MR0 408GS3TMR 000000HDMR5569 5853413T 00000300458MR7 RADNETMR594 00000287256MR2 305674MR1 000000HDMR6028 865218MR3T 000000HDMR4230 6109883TMR 00000276721MR8 407BDIMR 00000290478MR7 3017233TMR 00002982315MR9 ALLIANCESIG468 00000939BD5F59 310623MR 00000280229MR6 INSIGHTMR3233 00000296233MR0 515282MR1 00000280671MR9 RADNETMR1583 000000HDMR6392 602588CMR1 00000297726MR2 RADNETMR1589 N/A 407SMWPMR1 00001011BD6684 480464MR1 00000298718MR8 RADNETMR1595 0002005-1109-6 225763MR 00000299962MR1 RADNETMR590 00000300457MR9 RADNETMR1597 00000300769MR7 RADNETMR592 00000298773MR3 213387MR 35A14718B 626359MR3 000000HDMR3359 213777MR 00000265629MR6 405CDIMR 000000HDMR2303 269342MR3T2 00000283743MR3 808AMIMR 00000848BD531F RADNETMR612 000000HDMR3154 RADNETMR1659 00000275474MR5 RADNETMR615 CG10410053 631686MR3T 00001302FMM01K 661AIMR2 00000282794MR7 812450MR3 00000910BD57ED RADNETMR620 00001011BD6688 16683THDX 00000270465MR8 2901847MR3T 000000HDMR6209 422SIGNA3T 00000000WB0607 AZ4013MR01 00000290310MR2 030022MR01 00001009BD6557 BA4080MR01 00000286065MR8 2706164 00001012BD6695 2885417 00000008327YR9 2871974-1 00000299495MR2 MRWB0540 00000308026MR4 082427160103 00002951219MR0 082427310032 00001012BD66D9 082427160072 308735MR0 082427240048 00000299275MR8 082427200036 00000301930MR4 082427110034 00000302532MR7 082427240019 00000300770MR5 082427270032 00000301929MR6 082427100153 00000299539MR7 082427140077 00000299964MR7 082427140067 00000302533MR5 082427020037 00000303348MR7 082427190049 00000303428MR7 082427090164 00000307035MR6 082427160105 00000303446MR9 082427090174 00000302803MR2 082427120091 00000277601MR1 082427100161 00000301345MR5 082427090173 00000304164MR7 082427090171 0000000RUA2961 082427100164 RUA2993 082427100172 00000304519MR2 082427020041 00000304753MR7 082427060038 00000304871MR7 082427310048 305169MR5 082427030071 00000304886MR5 082427270030 00000305443MR4 082427090190 00000305136MR4 082427100173 00000305994MR6 082427150051 00000304844MR4 082427100185 00000305481MR4 082427150056 00001307FMM05N 082427110047 00000306779MR0 082427240030 RUA3884 082427100198 00000307080MR2 082427230068 00000306695MR8 082427150048 00000307122MR2 082427070101 00000307008MR3 082427240034 00000306356MR7 082427090208 00000303345MR3 082427160084 00000307478MR8 082427030086 00001309FMM01H 082427100176 00000304462MR5 082427110042 00000307181MR8 082427160117 309190MR7 082427040149 00000309346MR5 082427240041 00000308119MR7 082427090226 00000309572MR6 082427030090 00000309553MR6 082427070116 00000005341M23 082427190078 307476MR2 082427200056 00000307129MR7 082427190066 00000308106MR4 082427040147 37053 082427090232 0000000RUA3672 082427100201 00000305142MR2 082427120102 00000309812MR6 082427190075 0000000RUA5302 082427270040 310119MR3 082427060051 00000310109MR4 082427090229 00000307163MR6 082427160110 00000309344MR0 082427200052 00000310405MR6 082427090238 00000310049MR2 082427090246 00000305482MR2 082427110044 00000291977MR7 082427030106  082427010054  082427010065  082427010069  082427010077  082427010093  082427010095  082427070120  082427080044  082427100228  082427210127  082427240024 00000281019MR0 DK1030MR02 00000287917MR9 I4192908 00000285351MR3 583959MR01 00000939BD5F66 HC5284MR02 000000HDMR4364 HC1819MR01 00000272971MR3 493013MR01 00000287254MR7 083027022101691 N/A 083027041002010 00001012BD66E0 083027000143110 00001007BD6467 083027006495511 00000300459MR5 083027024220111 00001011BD661A 083027605826311 00000260694MR5 083027002730811 00000271248MR7 083027001106411 CG10410025 083027105227014 No Serial 083027609389015 00000273363MR2 0850270197 00000273674MR2 0850270202 00000280628MR9 0850270220 00000278845MR3 0850270218 00001007BD647E 0850270333 00000288210MR8 DVT0127 00000269454MR5 NO1005MR02 00001009BD6579 2887688HDX DUMFMI60876070 PL3040MR01 00000001526M23 PER08626 00001003BD640D PER28007 00000300683MR0 PER19516 00000938BD5F14 RO1189MR01 00000292316MR7 RU1971MR02 00000293651MR6 RU1688MR01 00000279146MR5 ZA2222MR01 00000265005MR9 DPM32124 00001006BD6463 DEL26444 00000299314MR5 NPV84502 00000300685MR5 ME051580 00000009454YR0 DPC79014  SY2012MR02 000000HDMR3898 0853270090 00000289162MR0 0853270094 00000298690MR9 00149MRS01  00624MRS04
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US: Nationwide including DC, PR and GU and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOSNIA HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GREECE, HONG Kong, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VENEZUELA.
  • Product Description
    GE Healthcare, SIGNA HDxt 3.0T. || Product Usage: || The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Manufacturer Address
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA