Events

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
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140518
  • 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

Device Recall GE Healthcare, Discovery MR750w 3.0T
  • 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 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  • Clasificación del producto
    Radiology Devices
  • 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
    GE Healthcare

Manufacturer

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