Events

Retiro De Equipo (Recall) de Device Recall Cerner Millennium RadNet Auto Launch Study and Auto Launch Report

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 Cerner Corp.

¿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
    44739
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1243-2007
  • Fecha de inicio del evento
    2007-08-23
  • Fecha de publicación del evento
    2007-09-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-11-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64345
  • 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
    radiology software - Product Code LLZ
  • Causa
    Defects in the auto launch functionality make it possible for a mismatch of patient data.
  • Acción
    The recalling firm initiated recall via telephone on 8/23/07 to their customers who had the 2007 version in their production environment, explained the reason for recall, and informed them they should turn off the affected functionality. The firm posted details of the situation on their website in two different documents (referred to as a Priority Review Flash), one dated 8/29/07 and the other dated 8/31/07. The 8/31/07 document was also mailed to their customers via certified mail on 9/4/07. The corrected software (EP28822 ver.1) was made available to the firm's clients on 9/7/07 via their website. Beginning 9/18/07, workarounds were discussed via telephone with the clients who had downloaded the software correction which contained a new bug that affected the dictation file. A new software correction to fix the dication file problem was posted on the recalling firm's website on 9/28/07 for clients to download and validate. A Priority review Flash #PR07-0176-2 client notification dated 10/4/07 was also posted on their website and mailed via certified mail return receipt.

Device

Device Recall Cerner Millennium RadNet Auto Launch Study and Auto Launch Report
  • Modelo / Serial
    Radiology 2007 Cumulative Production Package 25143
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution was made to health care facilities located in LA, MO, NJ, MS, MI, NE, ND, and AR.
  • Descripción del producto
    Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities.
  • Manufacturer
    Cerner Corp

Manufacturer

Cerner Corp
  • Dirección del fabricante
    Cerner Corp, 2800 Rockcreek Pkwy, Kansas City MO 64117-2521
  • Source
    USFDA