Events

Retiro De Equipo (Recall) de Device Recall MAGNETOM Avanto, Espree, Trio A Tim System

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 Siemens Medical Solutions USA, Inc.

¿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
    58080
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2021-2011
  • Fecha de inicio del evento
    2011-03-03
  • Fecha de publicación del evento
    2011-04-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98281
  • 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
    Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. the potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage.
  • Acción
    Siemens Medical Solutions Inc., issued a Customer Safety Advisory Notice dated November 24, 2010, to affected customers via Update Instructions MR029/10S. Affected customers will be notified via hand delivered letter by Siemens Service Engineers at the time of inspection. A future Update instruction will be released for installation of detectors in appropriate locations on systems to switch off the power electronics in the event of a malfunction in the power supply of the gradient coils. Further questions regarding this recall please call (610) 448-3237.

Device

Device Recall MAGNETOM Avanto, Espree, Trio A Tim System
  • Modelo / Serial
    Model numbers 10018165, 10018221, 10018222, 7387074, 7391167. 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  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was distributed domestically to hospitals and imaging centers in the District of Columbia, Puerto Rico, AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY(every State except VT).
  • Descripción del producto
    MAGNETOM Avanto, Espree, Trio A Tim System. || Nuclear magnetic resonance imaging.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA