Events

Recall of Device Recall GE Healthcare, SIGNA HDx 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-0258-2016
  • 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=140634
  • 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 HDx 3.0T
  • Model / Serial
    002003-0922-04 713441MR5 1583678 732632MR3 002003-1015-09 713441MR7 00001009BD6576 713792AMR12 000000HDMR5656 417269MRS1 00000HDMR10766 623433MR1 00000265552MR0 9525413TMR 00000026005MR8 503215MR1 002004-1102-17 7705353TMR 00000265805MR2 ACB41121MR HDMR5274 CBICMR1 0002005-0606-3 615284MR3T 000000HDMR5581 503216MR3 000000HDMR2301 269342MR3T 000000HDMR3234 303340MR 00000273869MR8 214345SWD3TMR1 000000HDMR2559 805GI3T HDMR2980 732223MR 00000275049MR5 706UGA3T 00000275649MR2 719595MR 00000275647MR6 3173383T1 #N/A 919684MR3 00000276435MR5 901226MR1 1002BD63EF 719542MR 00000275050MR3 631427MR3T 00000276722MR6 5857853T #N/A 5857853TTIP 00000273253MR5 717975MR3 00000007498YR9 212288GE3T 00000275967MR8 850916A3T 00000275648MR4 908725MR 00000278851MR1 425297RMR 00000006726YR4 COR373216 HM3652 715839MR3T 00000007556YR4 210617TCAMR2 00000HDMR10718 773665MR3T 00000278679MR6 708383WS3T 00000279918MR7 515643MR3T 00000279614MR2 904996MR3T 00000271119MR0 513556MR 00000280000MR1 630CDH3T 00000278678MR8 916KM3TMR 00000279613MR4 516562MR3T 00000279068MR1 805569MR 00000281154MR5 COR373219 00000282007MR4 4047783TMR 00000280949MR9 720848MR2 00000281342MR6 404772NMR3T 00000275646MR8 901572L3T 00000282796MR2 6622343TMR 00000280948MR1 650FALK3TMR 00000282731MR9 509474SH3T 00000280947MR3 2063203TMR 00000280670MR1 813251MR3T 00000276718MR4 MR129033 00000028261MR4 214433TN3TMR 00000282371MR4 7654493T 00000275650MR0 731935MR3 000000HDMR5671 323442MR3 000000HDMR3333 801IMCMR3 00000287415MR4 BEV3TMR 00000283027MR1 808591MR 00000283776MR3 480354MR1 00000284263MR1 2489643T 00000280231MR2 301496MR3T6MR 000000HDMR2685 301496MR3T5MR 00000285055MR0 850475IC3T 00000284234MR2 6053283TMR 00000286088MR0 540776MR3 00000283408MR3 CONCORD3T 00000286447MR8 217544MR1 00000280436MR7 8047643T 00000284576MR6 602406R3T 00000284575MR8 212639GE3T 000000HDMR1159 2187493T 00000282795MR4 480324MR1 00000286433MR8 828213MR 00000286478MR3 309655MRI3T 00000286744MR8 847SAMC3T 00000287255MR4 504447MR3 00000287417MR0 248551MR3T 000000HDMR3766 309672MR3T 000000HDMR5377 6053383TMR 000000HDMR5752 806NWTH3TMR 000000HDMR2824 907562P3T 000000HDMR4391 813972MR3T 000000HDMR5885 510939JMMR3T 000000HDMR5479 509434VA3T 000000HDMR5411 202865MR3T 000000HDMR5731 269341MR3T 000000HDMR5667 609497MR3T 000000C1081074 407OSCMR3T 000000HDMR2353 8043303T 00000290001MR7 304526CMR2 000000HDMR5892 205939MR4 000000HDMR4232 801373MR3 00000287566MR4 323268MR2 00000286089MR8 9786823T N/A 5204493T 000000HDMR5349 713524BIMR1 00000291755MR7 70389MR3T 00000291886MR0 703573MR6 00000291138MR6 ALLIANCESIG452 00000291747MR4 408885MR3T 00000291978MR5 412692MR1 00000292486MR8 970244MR3T 00000292079MR1 435688MR3 00000291979MR3 760323MR3T 00000296109MR2 601268MR3T SGH63105KY 214341PDGPMR1 4602WH9 RADNETMR617 00000276266MR4 817882H3TMR 000000HDMR5483 1063THDX 00000281888MR8 0910273032 000000HDMR3001 0910275006 000000HDMR3072 0910272053 000000HDMR5405 0910273033 00000HDMR10291 0910274020 000000HDMR5364 110028MR01 00000278843MR8 2644266 000000HDMR6091 2723694 00000298101MR7 MR13708YR3 00000265972MR0 2558948 00000280708MR9 2655437 00001001BD631C 2744287 00000HDMR10727 416369MR3T 00000279069MR9 604739MR 00000277190MR5 082427130033 00000HDMR10281 082427040073 000000HDMR3874 082427130037 000000HDMR5356 082427130038 00000288463MR3 082427050020 000000HDMR5413 082427010036 000000HDMR3086 082427140051 000000HDMR5478 082427120060 000000HDMR5530 082427040080 00000291137MR8 082427060026 00000280302MR1 082427040085 00000290489MR4 082427100102 00000291970MR2 082427020025 000000HDMR5896 082427030042 000000HDMR5345 082427250017 00000292027MR0 082427160064 00000304191MR0 082427130061 00000292030MR4 082427060025 00000905BD567A 082427130044 00000903BD55EA 082427270016 00000914BD5A77 082427220018 00000922BD5C3C 082427130042 000000HDMR5991 082427070055 00000919BD5BC2 082427070054 000000HDMR5757 082427040092 000000HDMR6163 082427130046 000000HDMR6035 082427140054 000000HDMR5511 082427310029 00000939BD5F50 082427210053 00000948BD61E4 082427010038 00001003BD6436 082427030050 00000903BD55FC 082427060028 00001003BD640C 082427080026 00001002BD6360 082427010041 00001003BD6433 082427110027 00001006BD6457 082427090124 00001008BD653C 082427070063 00001008BD651E 082427210060 00001010BD6606 082427090126 00000937BD5ED9 082427110026 00000290488MR6 082427090134 00001009BD65DF 082427030056 00001009BD657F 082427170008 00001008BD653D 082427040099 00001012BD66A6 082427120072 00001012BD66CC 082427040101 00000298935MR8 082427120070 00000299192MR5 082427140062 00000299191MR7 082427060032 00000950BD62B5 082427100119 00000299313MR7 082427090139 00000299312MR9 082427150037 00000914BD5A82 082427070062 00000950BD629C 082427090096 00001046XF5006 082427040105 00000298911MR9 082427100126 00000905BD5673 082427110025 00000288901MR2 082427060034 00000296468MR2 082427200039 00000301183MR0 082427120086 00000300952MR9 082427160081 00000300859MR6 082427120077 00000301928MR8 082427040113 00000298934MR1 082427300012 00000300682MR2 082427120083 00000300483MR5 082427010047 00000302534MR3 082427310046 00000300953MR7 082427310034 00000299963MR9 082427130062 00000299540MR5 082427130060 00000014816YR3 082427170012 00000304348MR6 082427090170 000000HDMR5459 082427100182 00000304487MR2 082427120093 000000HDMR3686 082427130077 00000306794MR9 082427090141 00000304192MR8 082427130059 0000000RUA4130 082427300018 00000938BD5F17 082427190069 00001315FMM00U 082427160086 0000000RUA4047 082427290013 00000304666MR1 082427160078 00000308802MR8 082427160113 00000293163MR2 082427220041  082427210070 00000279457MR6 CS1006MR03 00000266782MR2 DK1047MR04 00000291969MR4 FI1250MR01 00000277922MR1 M40345186 00000283745MR8 M4475661 00000292029MR6 A4194823 000000HDMR3319 H4858977  S41600123 00000001528752 MC6946MR07 00000007134YR0 PBOC01MR04 000000HDMR2544 PKOB02MR02 000000HDMR5286 HC0074MR01 00000286735MR6 H2193MR05 00000292524MR6 H10392MR03 00000282498MR5 083027802000517 00000286909MR7 083027821397268 N/A 083027007755738 00000285939MR5 083027002101567 000000HDMR4203 083027207848338 ACNA890724 083027009445910 00000270567MR1 IL1041MR06 000000HDMR2696 A5820844 000000HDMR4243 C5323526 000000HDMR5558 A5632416 00000288437MR7 A5508712 00000268047MR8 YM1394 00000268301MR9 YM1398 00000269332MR3 YM1399 00000268477MR7 YM1401 00000270097MR9 YM1395 00000268837MR2 YM1260 00000268692MR1 YM1410 00000268515MR4 YM1402 00000270528MR3 YM1261 00000267860MR5 YM1400 00000271662MR9 YM1411 00000270467MR4 YM1420 00000272536MR4 YM1430 00000272968MR9 YM1404 00000278128MR4 YM1801 00000278841MR2 YM1791 00000279421MR2 YM1790 00000279801MR5 YM1802 00000280701MR4 YM1792 00000283529MR6 YM1794 00000283037MR0 YM1796 00000285603MR7 YM1805 000000HDMR2727 YM1797 000000HDMR3495 YM1880 000000HDMR3135 YM1818 00000HDMR20030 YM1806 00000284210MR2 YM1840 00000HDMR20195 YM1819 000000HDMR5545 YM1440 00000288072MR2 YM1803 00000000003691 YM1799 00000HDMR20160 YM1820 000000HDMR5660 YM1811 00000292078MR3 YM1804 00000292028MR8 YM1813 00000292942MR0 YM1814 00000934BD5E50 YM1850 00000292983MR4 YM1815 00000289655MR3 YM1816 00000939BD5F56 YM1830 00000950BD629F YM1847 00000950BD6288 YM1817 00000952BD62FC YM1823 00000950BD6299 YM1825 00000950BD62B9 YM1870 000000HDMR5302 YM1827 00001002BD6375 YM1821 00001012BD66ED YM1835 00000298197MR5 YM1824 00001011BD668D YM1826 00000913BD5A5B YM1841 00000299274MR1 YM1831 00000296108MR4 YM1833 00000299315MR2 YM1832 00000296049MR0 YM1834 00000299316MR0 YM1849 00000290722MR8 YM1808 00000299666MR8 YM1829 00000937BD5F01 YM1822 00001002BD638C YM1828 000000HDMR3697 YM1807 000000HDMR5754 YM1812 000000HDMR5745 YM1810 00000300771MR3 YM1836 00001012BD66B0 YM1877 00000299665MR0 YM1837 000000HDMR2307 YM1789 00000299667MR6 YM1879 00000274387MR0 YM1793 000000HDMR2322 YM1795 000000HDMR1023 YM1798 00000HDMR10595 YM1881 00000834BD4B83 YM1809 000000HDMR4384 YM1800 00000275120MR4 YM1788 000000HDMR2541 YM1839 00000HDMR10853 YM1851 00000305168MR7 YM3900 00000308086MR8 YM3883 00000303640MR7 YM1882 00000303913MR8 YM1842 00000304488MR0 YM1843 00000302801MR6 YM1845 00000303910MR4 YM1848 00000304872MR5 YM1844 00000305143MR0 YM1846 00000306114MR0 YM3939 00000273816MR9 LB1000MR02 00000292640MR0 030013MR02 000000HDMR5960 0834270010 00000276270MR6 0920279024 00000279713MR2 RU1127MR02 00000275017MR2 RU1834MR01 000000HDMR3496 RU1884MR01 000000HDMR5821 RU1089MR04 000000HDMR5306 RU1588MR01 000000HDMR3963 SA1001MR03 00000291850MR6 RS4202MR01 000000HDMR3303 0847270022 00000918BD5B37 SI4024MR02 000000HDMR5973 ZA2169MR01 00000275644MR3 DEN51500 00000281189MR1 EPP00302 000000HDMR3229 DPN88605 00000950BD628D G002MR01 00000262064MR9 725030MR01 000000HDMR2831 899010MR02 000000HDMR3860 AE1190MR01 00000265957MR1 70043MRS04 00000270252MR0 10513MRS01 00000280672MR7 00440MRS02 000000HDMR3876 00240MRS01 000000HDMR5828 00042MRS01
  • 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 HDx 3.0T. Product Usage: The GE Signa HDx MR system is 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