Retiro De Equipo (Recall) de Innova 2000

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
    56988
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0393-2011
  • Fecha de inicio del evento
    2009-08-06
  • Fecha de publicación del evento
    2010-11-16
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-05-17
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Causa
    Ge healthcare has become aware of a potential video splitter failure with certain innova 2000 and 4100 x-ray systems that may impact patient safety. a potential video splitter failure inside the ge equipment cabinet could occur with no advance warning and thereby prevent x-ray image display. should this occur, the system cannot be recovered without service intervention. ge healthcare has obse.
  • Acción
    GE Healthcare sent an " Urgent Medical Device Correction" letter dated July 9, 2009, to Hospital Administrators / Risk mangers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter identified the product, described the Safety Issue, Affected Product Details, Safety Instructions Product correction and Contact Information. Hospitals were instructed to establish emergency workflow procedures should a component stop operating during a patient examination. A GE Healthcare service representative would contact each customer and correct all affected systems. For questions regarding this recall call (262) 548-2731.

Device

  • Modelo / Serial
    00000386307BU3 00000416240BU0 00000416671BU6 00000410737BU1 00000394213BU3 00000393185BU4 00000367089BU0 00000358524BU7 00000416632BU8 00000385319BU9 00000407956BU2 00000380196BU6 00000379745BU3 00000408100BU6 00000409042BU9 00000397053BU0 00000346261BU1 00000388459BU0 00000366739BU1 00000395215BU7 00000380627BU0 00000343649BU0 00000392274BU7 00000376219BU2 00000400526BU0 00000415567BU7 00000375036BU1 00000377023BU7 00000340384BU7 00000361277BU7 0000395214BU02 00000403889BU9 00000340373BU0 00000408600BU5 00000394213BU3 00000399595BU8 00000404101BU8 00000419220BU9 00000418004BU8 00000416123BU8 00000427532BU7 00000351550BU9 00000393733BU1 00000411171BU2 00000367495BU9 00000419070BU8 00000382939BU7 00000407088BU4 00000352612BU6 00000378676BU1 00000338024BU3 00000347472BU3 00000382816BU7 00000391288BU8 00000381847BU3 00000354201BU6 00000373281BU5 00000385862BU8 00000408597BU3 00000406234BU5 00000397051BU4 00000416881BU1 00000374925BU6 00000387300BU7 00000358211BU1 00000386952BU6 00000340820BU0 00000394045BU9 00000379434BU4 00000380940BU7 00000378710BU8 00000344212BU6 00000420895BU5 00000416788BU8 00000415705BU3 00000349342BU6 00000368219BU2 00000375037BU9 00000378066BU5 00000379337BU9 00000341066BU9 00000349343BU4 00000321665BU2 00000324194BU0 00000351993BU1 00000392236BU6 00000392999BU9 00000375409BU0 00000392245BU7 00000340211BU2 00000340822BU6 00000347108BU3 00000416885BU2 00000392766BU2 00000366245BU9 00000392580BU7 00000332824BU2 00000338723BU0 00000340790BU5 00000420495BU4 00000332678BU2 00000385405BU6 00000342460BU3 00000366737BU5 00000394210BU9 00000418299BU4 00000350866BU0 00000367496BU7 00000378074BU9 00000406792BU2 00000393732BU3 00000380199BU0 00000389098BU5 00000403800BU6 00000342699BU6 00000322232BU0 00000410945BU0 00000367087BU4 00000416241BU8 00000366244BU2 00000370167BU9 00000374489BU3 00000399753BU3 00000408875BU3 00000411395BU7 00000327810BU8 00000379404BU7 00000364518BU1 00000399750BU9 00000403125BU8 00000341530BU4 00000419394BU2 00000407955BU4 00000333964BU5 00000334722BU6 00000383540BU2 00000392563BU3 00000338553BU1 00000417921BU4 00000413030BU8 00000416580BU9 00000417594BU9 00000417599BU8 00000309161BU8 00000409163BU3 00000372500BU9 00000351549BU1 00000407957BU0 00000341260BU8 00000382096BU6 00000346259BU5 00004093368BU8 00000367086BU6 00000397644BU6 00000397643BU8 00000389796BU4 00000389994BU5 00000417673BU1 00000419495BU7 00000410336BU2 00000367497BU5 00000381708BU7 00000392468BU5 00000418005BU5 00000368220BU0 00000413390BU6 00000381846BU5 00000341095BU8 00000397050BU6 00000342077BU5 00000382876BU1 00000386741BU3 00000374480BU2 00000381436BU5 00000409300BU1 00000383992BU5 00000382815BU9 00000389501BU8 00000400151BU7 00000364519BU9 00000386059BU0 00000388900BU3 00000407950BU5 00000408333BU3 00000413029BU0 00000404678BU5 00000413030BU8 00000373302BU9 00000375205BU2 00000389096BU9 00000406785BU6 00000374684BU9 00000401024BU5 00000411170BU4 00000416729BU2 00000401502BU0 00000401211BU8 00000331854BU0 00000380939BU9 00000340821BU8 00000368221BU8 00000416864BU7 00000375351BU4 00000405951BU5 00000395517BU6 00000375351BU4 00000399715BU2 00000416963BU7 00000418000BU6 00000341536BU1 00000324770BU7 00000417861BU2 00000421110BU8 00000409162BU5 00000354200BU8 00000418425BU5 00000393646BU5 00000351997BU2 00000400746BU4 00000419167BU2 00000329435BU2 00000329435BU2 00000380451BU5 00000364181BU8 00000393647BU3 00000379761BU0 00000423003BU3 00000415056BU1 00000383125BU2 00000415052BU0 00000382940BU5 00000421317BU9 00000415178BU3 00000359557BU6 00000334721BU8 00000343648BU2 00000343653BU2 00000377021BU1 00000377607BU7 00000378073BU1 00000387849BU3 00000387866BU7 00000389235BU3 00000397407BU8 00000397641BU2 00000398007BU5 00000404103BU4 00000405768BU3 00000417028BU8 00000418197BU0 00000401600BU2 00000404104BU2 00000389995BU2 00000390720BU1 00000409830BU7 00000415426BU6 00000358906BU6 00000404082BU0 00000364940BU7 00000410853BU6 00000415702BU0 00000350882BU7 00000380890BU4 00000352273BU7 00000386409BU7 00000411914BU5 00000375337BU3 00000398009BU1 00000398008BU3 00000342264BU9 00000354848BU4 00000383127BU8 00000400349BU7 00000367088BU2 00000418046BU9 00000402250BU5 00000405330BU2 00000407081BU9 00000409301BU9 00000343646BU6 00000344211BU8 00000342263BU1 00000346257BU9 00000350884BU3 00000352274BU5 00000367494BU2 00000368222BU6 00000369298BU5 00000372953BU0 00000382386BU1 00000389446BU6 00000398010BU9 00000400186BU3 00000400664BU9 00000401287BU8 00000410223BU2 00000412511BU8 00000324692BU3 00000347109BU1 00000376220BU0 00000377864BU4 00000378675BU3 00000381435BU7 00000391181BU5 00000398913BU4 00000405374BU0 00000408840BU7 00000348537BU2 00000369297BU7 00000365380BU5 00000342700BU2 00000352271BU1 00000361953BU3 00000380382BU2 00000409001BU5 00000412931BU8 00000420110BU9 00000344209BU2 00000377865BU1 00000383390BU2 00000410669BU6 00000415820BU0 00000374276BU4 00000380585BU0 00000400097BU2 00000418416BU4 00000420032BU5 00000330432BU6 00000361743BU8 00000384940BU3 00000350886BU8 00000334723BU4 00000334724BU2 00000342698BU8 00000366741BU7 00000371685BU9 00000377608BU5 00000381174BU2 00000387191BU0 00000388258BU6 00000388606BU6 00000393734BU9 00000394046BU7 00000395213BU2 00000395516BU8 00000395518BU4 00000397408BU6 00000397645BU3 00000403958BU2 00000411199BU3 00000347469BU9 00000349890BU4 00000354852BU6 00000364939BU9 00000397054BU8 00000417895BU0 00000419496BU5 00000343061BU8 00000339405BU3 00000397642BU0 00000330900BU2 00000377022BU9 00000382385BU3 00000415812BU7 00000416277BU2
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX UT, VA, WA, WV, and WI, and the countries of UNITED KINGDOM, TUNISIA, TAIWAN, PROVINCE OF CHINA, SPAIN, SOUTH AFRICA, SAUDI ARABIA, RUSSIAN D=FEDERATION, POLAND, NORWAY, NEW ZEALAND, NETHERLANDS, MEXICO, MARTINIQUE, LITHUANIA, LEBANON, REPUBLIC OF KOREA, JORDAN, JAPAN, ITALY, IRELAND, ISLAMIC IRAN, INDONESIA, INDIA, GREECE, GERMANY, FRANCE, FINLAND , EGYPT, CHILE, CANADA, BULGARIA, BELGIUM BELARUS, AUSTRALIA.
  • Descripción del producto
    Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. || The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These system can be operated in a mobile or fixed site environment.
  • Manufacturer

Manufacturer

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