Retiro De Equipo (Recall) de GE Healthcare Discovery and Optima

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, LLC.

¿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
    68141
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1533-2014
  • Fecha de inicio del evento
    2014-04-23
  • Fecha de publicación del evento
    2014-05-01
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2015-01-21
  • 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
    Ge healthcare has recently become aware of a potential safety issue with certain ge mri products. patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. this could make the safe removal of the patient from the system difficult.
  • Acción
    Consignees were sent on 4/23/2014 a GE Healthcare Ref # 60863 "Urgent Medical Device Correction" letter dated April 18, 2014. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Mangers and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. If customers encounter the stated problem with the device, they should contact their GE Healthcare Service Representative for an inspection and necessary repairs. GE will correct all affected devices at no cost to the customers. For questions customers should contact their local service representative.

Device

  • Modelo / Serial
    Mfg Lot or Serial # SystemID 00001250FMM026 919684DMPMR1 00000301309MR1 6628 00000000HM0426 6947 00000305379MR0 7462 00001018XF503B 205592750 00001227FMM00T 201445750W 00000297006MR9 202476MR1 00000296307MR2 202476MR2 00000297727MR0 202476MR3 00000300562MR6 202476MR4 00000000UA0153 202966MR3TW 00000305414MR5 203739MR450W 00000301842MR1 203863MR450W 00001203FMMOUJ 205750MR5 00000298836MR8 205838MR4 00000298249MR4 205949MR450W 00000301841MR3 206292SR450W 00000000UA0026 206292SR750W 00000293338MR0 206CH750MR 00000295024MR4 207945MR750 00001250FMM033 207OA450WMR 00000305461MR6 208882MR450W 00000299644MR5 209225VC450 00001026XF5173 209225VC750 00001105XF502C 209SJMR 00000000UA0143 210617HUBMR 00000300706MR9 210MSMTMR 00000000UA0052 21277MR1 00000301045MR1 212989MR1 00000305990MR4 212GE450W 00000301820MR7 214266PCBCMR1 00000302494MR0 214302PDWMR1 00000300930MR5 214590MWMRE3 00001250FMM02W 214645UT3TMR1 00000030251MR2 215ARIA450W 00000304079MR7 217223BHMR 00000303322MR2 217258SBMR1 00000294098MR9 217383CMR5 00000291464MR6 217528MR1 00000000HM0640 217532DVMR 00000299560MR3 217732LMR 00000292843MR0 217788MR3 00001250FMM02E 217876DMH3T 00000307113MR1 217876FMR 00000303450MR1 218828MR 00000000UA0203 225763MR2 00000306130MR6 229228450W 00000123FMM0K4 239VA450MR 00000296369MR2 240215MR 00000302363MR7 240313MR 00000301471MR9 240683MR 00000292634MR3 2486613TMR 00000298535MR6 252436MPMR 00000299171MR9 252482MR450 00001250FMM02T 252NDMR450W 00000296070MR6 253596GHTMR 00001307FMM05K 256881MR1 00001301FMM04T 256HHMR2 00000296840MR2 256HICMR2 00000302944MR4 256ODCMR1 00000303639MR9 260426VAMR 00000301255MR6 260920MR 00000302633MR3 262656MR1 00000301867MR8 262687MR1 00000308096MR7 262785mr1 00000295802MR3 269DVMR 00000000UA0138 270798MR2 00000294057MR5 281274MR1 00000000UA0028 281274MR2 00000290050MR4 281276MR750 00000298727MR9 281348450WMR 00000296429MR4 281364MR2 00001001BD6325 281477MR2 00000304177MR9 301295MR3T2 00000295215MR8 301295MR4 00001106XF5046 301295MR5 00000301518MR7 301295MR6 00000000UA0027 3014643TMR 00000300687MR1 301496MR3T4 00001301FMM047 301570MR 00000000HM0570 301618MR2 00001234FMM0J4 302993MR 00000298675MR0 303278MR 00000000HM0583 303338MR1 00000000HM0591 303338MR2 00000303940MR1 303426MR 00000304578MR8 303427MRW 00000303646MR4 303444MR 00000000UA0029 303604MR2 00000299213MR9 303699MR2 00000294494MR0 304256MR2 00000302631MR7 304766MR4 00000302248MR0 305243MR1 00001245FMM03P 305284MR1 00000000UA0085 305461MR1 00000304493MR0 305854MR1 00000301046MR9 308398HDMR 00001301FMM04G 309344MR450W 00000296469MR0 309662JMR450W 00000305101MR8 309672MR450W 00000296046MR6 309683MNMR750 00000305519MR1 310289MR 00000303805MR6 312355DVMR 00000301924MR7 312996MR3T 00000299952MR2 313593MR450 00000000UA0091 314577CGMR3T 00000301262MR2 315SOS450W 00000305521MR7 315SOSNORTH 00000303342MR0 316685MR 00001250FMM036 317338MR5 00000298399MR7 317865MR3 00000301519MR5 317887MR2 00000301190MR5 318769MR 00000299522MR3 319268MR 00000304355MR1 321FCMR1 00001301FMM045 330263450W 00000000UA0116 330344MR750W 00000300847MR1 330363450W 00000305176MR0 330489MR450W 00000000UA0144 337289MR1 00000000UA0074 337943MR1 00000029854MR5 352867MR 00000300987MR5 360507450WCM 00000298512MR5 360582450WPA 00000000UA0056 386FHPCMR3T 00000296908MR7 386FMR3T 00000302570MR7 402228MR 00000301013MR9 404329MR 00000000UA0034 405271OUCMR 00000299491MR1 405359EMR 00000302712MR5 405486MR 00000293561MR7 405752I3T 00000304151MR4 405912MMR 00001219FMM0GV 406375HMR 00000299141MR2 406543MR450W 00000305668MR6 407PMCMR 00000000UA0068 407SMSLMR1 00000000UA0083 408356MR1 00000302916MR2 412372MR1 00000299967MR0 412623MR1 00000300564MR2 412623SDHYMR3 00000298677MR6 412647PUHMR1 00000300494MR2 412647PUHMR2 00000298960MR6 412835MR1 00000306066MR2 412942MR2 00001307FMM01X 413568MR 00000000UA0167 414647MR1 00000298889MR7 414649WB3 00000298552MR1 414805MR1 00000298591MR9 414805MR2 00000300122MR9 414805MR4 00000297624MR9 415493VMR2 00000290202MR1 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  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, except ND, RI and WY, and including DC, Guam, and Puerto Rico; and, the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA,AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CAYMAN ISLANDS, CHINA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KOREA, KUWAIT, LEBANON, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, T UREY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, and VENEZUELA.
  • Descripción del producto
    GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. || Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices.
  • Manufacturer

Manufacturer

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