Retiro De Equipo (Recall) de Device Recall GE Healthcare, Discovery MR750w 3.0T

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por GE Healthcare.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    72301
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0254-2016
  • Fecha de inicio del evento
    2015-08-31
  • Fecha de publicación del evento
    2015-11-10
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    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.
  • Acción
    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

  • Modelo / Serial
    00000302690MR3 HCIMR1805 00000290502MR4 MR129030 00000291489MR3 415723SHMR10 00000294472MR6 650723SSMR1 00000290704MR6 650723SSMR2 00000289310MR5 HSSMR750 00000289961MR5 SINAI750MR 00000290457MR1 608263MR6 00000290050MR4 281276MR750 00000290659MR2 610740MR3 00000290202MR1 415723CHMR2 290957MR0 608HERIMR 00000290636MR0 MR129034 00000290137MR9 650723NCMR1 00000289309MR7 650723NCMR2 00000291397MR8 517353DVMR 00000291363MR0 616391DVMR 00000291980MR1 704384DVMR 00000292367MR0 INSIGHTMR3228 00000292471MR0 804675VA3T 00000288408MR8 608WAISMR 00000292634MR3 2486613TMR 00000288907MR9 MR129035 00000292431MR4 541CMRIMR 00000290773MR1 415L3TMR2 00000291877MR9 415L3TMR1 00000291185MR7 MSK65MR1 00000292528MR7 608WIMRMR2 00000291244MR2 MSK65MR2 00000293338MR0 206CH750MR 00000291464MR6 217528MR1 00000292843MR0 217788MR3 00000294556MR6 540665MR3T 00000293261MR4 415OI3TMR 00000293015MR4 910907WAMR1 00000292678MR0 919684MR5 00000293561MR7 405752I3T 00000293874MR4 HSSGMR750 00000294018MR7 903525MR750 00000000000641 434UVAMR 00000294057MR5 281274MR1 00000294576MR4 602830MR3 00000294698MR6 812485MR3 00000294665MR5 480768MR2 00000294718MR2 715838MR3T 00000295112MR7 801377MR3 00000295024MR4 207945MR750 00000295111MR9 703391MR2 00000294953MR5 7579533T 00000295802MR3 269DVMR 00000295228MR1 6036503T 00000296046MR6 309683MNMR750 00000295904MR7 281477MR2 00000295506MR0 858822HDMR1 00000296014MR4 816932DVMR 00000296640MR6 617726MR1A2 00000296512MR7 916LST3TMR 00000296461MR7 MR129037 00000294999MR8 MSK68MR4 00000295215MR8 301295MR4 00000296602MR6 7168453T 00000296821MR2 DUPONT3T 00000294398MR3 713441MR9 00000296114MR2 713441MR8 00000297469MR9 954772MR1 00000296517MR6 615MTMR1 00000297974MR8 810235DVMR 00000297624MR9 415493VMR2 00000296908MR7 386FMR3T 00001106XF511E 202476MR3 00000298283MR3 616494DVMR 00000298591MR9 414805MR2 00000298677MR6 412647PUHMR1 00000298420MR1 6162673T750 00000298537MR2 832522MR1 00000298765MR9 9155693TMR 00000298981MR2 480425MR6 00000297374MR1 650PH3T 00000298738MR6 RADNETMR1593 00000299181MR8 703858MR3T 00000297637MR1 650723PSYMR 00000299213MR9 303699MR2 00000299291MR5 205592750 00000299250MR1 847618MR1 00000299321MR0 509473DMR3T 00000299406MR9 713792CMR1 00000298580MR2 570271MR6 00000299515MR7 816698CP3T 00000299966MR2 540MIF3T750 00000299329MR3 209225VC750 000000HDMR6188 301496MR3T4 00000299544MR7 703805MR3 00000299908MR4 425750PMR 00000299331MR9 720321MR 00000300713MR5 425688MR 00000299411MR9 920288MR750 00000301049MR3 707DG3T 00000300793MR7 BMDACCMR1 00000300122MR9 414805MR4 00000301752MR2 858822HDMR2 00000300562MR6 202476MR4 00000300732MR5 805687MR1 00000301924MR7 312996MR3T 00000299967MR0 412623MR1 00000301295MR2 415723SCHMR2 00000302248MR0 305243MR1 00000301926MR2 510537MR750 00000303805MR6 312355DVMR 00000000UA0057 415723SHMR12 00000302688MR7 607CORNELL3T 00000000UA0071 585275MR750W 00000303439MR4 713566SMITH2 00000304177MR9 301295MR3T2 0000000UA0032A 808485MR2 00000301597MR1 UM750MR 00000304508MR5 585785MR750 00000304536MR6 904202MR9 00000304836MR0 919684BIAC6 00000030493MR0 602839MR1 00001105XF503F ASLW750 00000305165MR3 415723CHMR3 00000290605MR5 661KRMR750 00000306640MR4 305284MR1 00000307132MR1 7347633TMRFIX 00000306641MR2 212543MR750 00000308791MR3 415MB3T 00000308357MR3 650780MR750 00000309403MR4 918491MR2 00000307553MR8 415UCBHMR1 00000309564MR3 415UCBHMR2 00000293065MR9 918491MR1 00000301599MR7 703573MR2DV UA0348 MR229049 N/A 858657HDMR3 00000310141MR7 AM12O59187 N/A 408358SHMR13 00000291429MR9 0910274032 00000914BD5A87 0910272064 00001007BD6466 0910272071 00001011BD663A 0910272072 00000297898MR9 2875893 00000295060MR8 MR13905YR5 00001012BD66AE MRWB0558 00001301FMM048 MRUA0184 00000291154MR3 519685MR3T 00000291008MR1 416486MR3T 00000296200MR9 905527MR1 00000298951MR5 514345BMR1 00000300711MR9 514848MR1 00000000UA0042 403229MR1 00000300563MR4 905522MR3T 00000303327MR1 604875MR750 00000299547MR0 403944MR1 00000296265MR2 416595MR1 000000000R2726 902473MR2 00000310044MR3 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083027200034313 00001204FMM054 083027062157412 00001309FMM052 083027860052014 00000309951MR2 083027861452415 00000310060MR9 083027246282014 00000310161MR5 083027244278914 No Serial 083027046705715 ACD4001507 083027200005613 00001203FMM0V5 0835270026 00000000UA0205 IE1010MR01 00001203FMM0VY B5129925 00001309FMM07R B5174327 00001309FMM05G A5360437 00000307437MR4 A5111746 00000310162MR3 A5547422 00001134FMM10L EM0201 00001112FMM081 EM0202 00000302811MR5 EM0203 00001117FMM0CE EM0204 00001140FMM0FU EM0205 00001221FMM0BB EM0210 00001233FMM072 EM0206 00001220FMM01J EM0207 00001147FMM0EE EM0222 00001203FMMOUW EM0212 00001227FMM00V EM0211 00001234FMM0KH EM0223 00001236FMM00M EM0215 00001221FMM06R EM0220 00001227FMM00J EM0208 00001236FMM01R EM0214 00001203FMM0V2 EM0230 00001220FMM01H EM0209 00001236FMM01G EM0213 00001140FMM0FL EM0218 00001203FMM0VX EM0219 00001233FMM076 EM0250 00001236FMM00X EM0216 00000305986MR2 EM0224 00001147FMM0E8 EM0217 00001234FMM0KA EM0221 00001227FMM00C EM0225 00001250FMM01W EM0227 00001250FMM02U EM0228 00001250FMM02G EM0226 00001308FMM055 EM0231 00001308FMM04T EM0229 00001308FMM05B EM0234 00001308FMM063 EM0232 00001301FMM04H EM0235 00001236FMM04W EM0237 00001301FMM04V EM0233 00001236FMM04P EM0271 00001308FMM05M EM0272 00001236FMM01H EM0241 00001236FMM020 EM0240 00001250FMM02Y EM0236 00001308FMM027 EM0242 00001236FMM016 EM0238 00001236FMM05E EM0239 00001236FMM05U EM0246 00001309FMM06A EM0245 00001308FMM022 EM0244 000000HDMR4067 EM0260 00001309FMM08Y EM0243 00001309FMM05Y EM0247 00001308FMM01P EM0255 00001308FMM020 EM0256 00001308FMM03L EM0248 00001308FMM00E EM0253 00001309FMM09Y EM0257 00001308FMM012 EM0254 00001308FMM01Y EM0249 00001309FMM08H EM0258 00001308FMM01U EM0265 00001309FMM095 EM0275 00000000UA0358 EM0259 00000308840MR8 EM0261 00000309816MR7 EM0262 00000310059MR1 EM0270 00000310063MR3 EM0263 00000310420MR5 EM0266 00000310421MR3 EM0281 00000310474MR2 EM0267 00000310475MR9 EM0264 00000310677MR0 EM0268 00000310720MR8 EM0280  EM0278  EM0279 00000310702MR6 EM0277  EM0269  EM0273 00000310839MR6 EM0276 00000310903MR0 EM0274 00000310105MR2 KA1023MR02 00001233FMM06M 0850270414 00001204FMM04V 0850270386 00001227FMM00X 0850270411 00000000UA0170 0850270427 00001250FMM03E 0850270426 00000306791MR5 0850270430 00001221FMM06X 0850270409 00001308FMM02H 0850270436 00001309FMM04W 0850270446 00001309FMM055 0850270455 00001236FMM05A KW1005MR04 00001309FMM096 KW1019MR03 00000310542MR6 KW1100MR02 00000301969MR2 LB1331MR01 00001250FMM028 LB1160MR02 00001301FMM04M LB1006MR02 00000308183MR3 MR308183MR3 00001147FMM0E6 UDN0121 00000304860MR0 RTD0191 00001140FMM0G4 0920279031 00001308FMM052 85092252519 00000310773MR7 85110163303 00001250FMM02P 600042MR02 00001308FMM05H PL3116MR01 00001309FMM0AE PL3277MR01 00001308FMM05C QA1042MR01 00001204FMM04A RO1098MR02 00001234FMM0KG RU5599MR01 00000000UA0227 RU8438MR01 00000000UA0229 RU8438MR03 00001308FMM03B RU8615MR01 00001307FMM08M RU8792MR01 00000310164MR9 RU8937MR01 00000310220MR9 RU1717MR01 00001135FMM019 SA1033MR01 00001308FMM064 SA1223MR01 00001309FMM05E SA1255MR03 00000309329MR1 SA1058MR03 00000000UA0023 0847270026 00001142FMM096 MPX94401 00001309FMM08R UE929526 00000000UA0425 DPN36500 00001134FMM10D A010MR08 00001251FMM01P M001MR02 00001309FMM05J N002MR03 00000306343MR5 M004MR01 00000306349MR2 O009MR03 00000308132MR0 T002MR01 00001142FMM092 120810MR02 00000000UA0049 850020MR02 00001250FMM039 387040MR10 00001309FMM06W 725100MR02 00000309270MR7 150250MR01  259130MR12 00001308FMM048 0853270141 00000310604MR4 0856270071 00001204FMM04B 34348MRS01 00001227FMM00N 26001MRS01 00000000UA0349 53008MRS01 00000309272MR3 06162MRS01 00000000UA0097 AE1016MR01 00001111FMM0B7 70431MRS04 00001250FMM038 00010MRS02 00000000UA0265 00230MRS01 00001309FMM04T 10692MRS01 00001309FMM07M 77266MRS03 00000310701MR8 20312MRS01 00000302616MR8 10639MRS01 00000302669MR7 10678MRS01 00000309906MR6 MRUA0353
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    GE Healthcare, Discovery MR750w 3.0T. || Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA