Events

Retiro De Equipo (Recall) de Device Recall MR Systems

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
    26218
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1087-03
  • Fecha de inicio del evento
    2003-02-28
  • Fecha de publicación del evento
    2003-08-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-12-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27286
  • 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
    Software problem this error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.
  • Acción
    The recalling firm issued three separate customer advisory letters dated 2/28/03, 03/01/03, and 4/14/03 to their customers explaining the problem and the preventive measure to avoid loss of information.

Device

Device Recall MR Systems
  • Modelo / Serial
    Upgrade Harmony Syngo MR, model 7106714 K2200 Serial # 10501 through 10587. Harmony Syngo MR, model 7104693 K2200 Serial # 11001 through 11172. Upgrade Symphony Syngo MR, model 7106557 K 2210 Serial # 14001 through 14321. IMPACT - Upgrade Syngo MR (MU3S), model 5751438 K2220 Serial # 15001 through 15030. IMPACT - Upgrade Syngo MR (MU3L), model 7106466 K2220 Serial # 15501 through 15519. VISION - Upgrade Quantum, model 4772971 K2230 Serial # 16001 through 16017. VISION - Upgrade Sonata, model 7388148 K2230 Serial # 16501 through 16513. Concerto Upgrade, model 7106995 K2221 Serial # 17201 through 17211. Concerto, model 4772906 K2221 Serial #17301 through 17473. Syngo Allegra, model 7106433 K2183 Serial #20101 through 20110. Upgrade Allegra syngo MR, model 7387736 K2183 Serial # 20401 through 20421. Trio (Bruker), model 7106441 K2180 Serial #20500 through 20507. Trio, model 7387074 K2180 Serial #20510 through 20524 and 20550 through 20552. Sonata Syngo MR, model 7104719 K2240 Serial #21101 through 21248. Syngo MR SYM-Sonata-Upgrade, model 7104735 K2240 Serial #21604 through 21612. Syngo MR Upgrade Sonata, model 7106425 K2240 Serial #21901 through 21942. Symphony syngo MR, model 7104594 K2210 Serial 22001 through 22996. Rhapsody, model 7384568 K2190 Serial #24001 through 24004.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The product was shipped to distributors, medical facilities and Siemens training facilities nationwide.
  • Descripción del producto
    MR Systems
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Parkway, Malvern PA 19355
  • Source
    USFDA