Events

Retiro De Equipo (Recall) de Device Recall ISOLOC Software

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 Civco Medical Instruments 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
    48463
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2137-2008
  • Fecha de inicio del evento
    2008-06-18
  • Fecha de publicación del evento
    2008-09-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-03-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71476
  • 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
    Linear Medical Accelerator - Product Code IYE
  • Causa
    A localization may be produced which has the incorrect moves, and therefore, could place the patient in the incorrect location.
  • Acción
    On 06/16/08 Civco Medical Solutions issued an Urgent-Medical Device Correction letter to all its customers by certified mail. This letter states the circumstances in which the device works incorrectly, a temporary work around and the information that the new software version 6.7 will address the issue. The software will be released in August of 2008. Attached to the letter is an ISOLOC Device Correction Notification Customer Feedback form which is to be completed and returned acknowledging the receipt of the Device Correction Notification.

Device

Device Recall ISOLOC Software
  • Modelo / Serial
    Versions 6.6, 6.5 and 6.0
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- USA including Puerto Rico and countries of Korea, Portugal, and United Kingdom.
  • Descripción del producto
    Isoloc Software, Version 6.6, 6.5 and 6.0. Part Number MT-NW-425-520. Software computer hard disc reads "ISOLOC 6.6 Copyright NMPE Copyright 1997-2004 NMPE Build #10302006 CIVCO MEDICAL SOLUTIONS || Is an EPID-based (electronic portal imaging device) version of localization software for determining the treatment machine position of radiotherapy targets.
  • Manufacturer
    Civco Medical Instruments Inc

Manufacturer

Civco Medical Instruments Inc
  • Dirección del fabricante
    Civco Medical Instruments Inc, 102 1st St S, Kalona IA 52247-9589
  • Empresa matriz del fabricante (2017)
    Roper Technologies Inc
  • Source
    USFDA