Events

Retiro De Equipo (Recall) de Device Recall AccuSeed DS Digital Stepper

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 Computerized Medical Systems 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
    36665
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0221-2007
  • Fecha de inicio del evento
    2006-11-09
  • Fecha de publicación del evento
    2006-11-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-11-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49115
  • 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
    radioactive seed placement system - Product Code ITX
  • Causa
    The in/out adjustment knob can be over-turned, ultimately causing the incorrect placement of radioactive seeds in the patient.
  • Acción
    The recalling firm issued letters dated 11/9/06 via regular mail. The letter informs the customer of the problem and includes an advisory notice instructing them to perform a test prior to each use. If the system does not function correctly, it can still be used safely in a manual mode until it can be returned for repair. A questionnaire was enclosed that will facilitate the firm in prioritizing repairs and retrofits. After the questionnaire is reviewed, the firm will contact the customer for further information regarding their facilities use of the device. This letter was also issued to the CMS customer support departments in Japan, China, and Europe, who will notify the foreign customers and prioritize their returns for repair.

Device

Device Recall AccuSeed DS Digital Stepper
  • Modelo / Serial
    All Model #DS300 steppers
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Australia, Japan, China, France, Germany and Brazil.
  • Descripción del producto
    AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system. Model #DS300
  • Manufacturer
    Computerized Medical Systems Inc

Manufacturer

Computerized Medical Systems Inc
  • Dirección del fabricante
    Computerized Medical Systems Inc, 1145 Corporate Lake Dr Ste 100, Saint Louis MO 63132-1716
  • Source
    USFDA