Events

Retiro De Equipo (Recall) de Device Recall 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 Medical Systems, 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
    52703
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2240-2009
  • Fecha de inicio del evento
    2009-07-31
  • Fecha de publicación del evento
    2009-09-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83678
  • 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 recently became aware of a potential power supply failure with the innova¿ 2000, 3100 and 4100 systems that may impact patient safety. a potential power supply failure inside the ge equipment cabinet could occur with no advance warning and thereby prevent x-ray generation and image processing. should this occur, the system cannot be restarted.
  • Acción
    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated June 25, 2009. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology or Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. GE Healthcare will correct all affected systems by replacing the power supply located in the GE equipment cabinet. A GE Healthcare service representative will contact you to arrange for this correction. Direct questions about the recall to the firm's Call Center by calling: 1-800-437 -1171, option 4 (United States) or 0120 - 055 - 919 (Japan). For other countries, please contact your local GE Healthcare field service Representative if you have any questions or concerns regarding the notification.

Device

Device Recall Innova 2000
  • Modelo / Serial
    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422771BU6 00000421701BU4 00000422469BU7 00000394209BU1 00000392580BU7 00000416864BU7 00000418000BU6 00000407955BU4 00000406792BU2 00000427204BU3 000000393456U9 00000406785BU6 00000394044BU2 00000408600BU5 00000421608BU1 00000411914BU5 00000423019BU9 00000398007BU5 00000389235BU3 00000397408BU6 00000387191BU0 and 00000403958BU2.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US (states of AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA., MI, MN, MO, NE, NV, NH, NJ, NY, NC, OH, OK , OR, PA, PR, RI, SC, TN, TX, UT VA, WA, WI and WV), TUNISIA, THAILAND , TAIWAN, SYRIAN ARAB REPUBLIC, SWEDEN SPAIN, SOUTH AFRICA SAUDI ARABIA, RUSSIAN FEDERATION , POLAND, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MARTINIQUE, MACAU, LEBANON, KUWAIT, REPUBLIC OF KOREA, JAPAN, ITALY, ISRAEL, IRAN, INDONESIA, INDIA, GREECE, GERMANY, FRANCE , CHINA, CANADA, BULGARIA, BRAZIL BELGIUM, BELARUS and AUSTRALIA.
  • Descripción del producto
    GE, Innova¿ 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. || Innova¿ 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

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