Events

Retiro De Equipo (Recall) de Device Recall Performa TM300 Traction 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 Sammons Preston Rolyan, An Ability One Company.

¿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
    31492
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1444-05
  • Fecha de inicio del evento
    2005-07-13
  • Fecha de publicación del evento
    2005-08-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-01-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37983
  • 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
    Apparatus, Traction, Non-Powered - Product Code HST
  • Causa
    The traction device may malfunction, producing oscillation and a jerking motion.
  • Acción
    Sammons Preston Roylan, the U.S. agent for Ito Co., Ltd. issued recall letters dated 7/13/05 to all of their customers who purchased the Performa TM-300 traction unit, informing them that the manufacturer, Ito Co., Ltd., is recalling the units because the units may exhibit oscillation during some traction modes. The accounts were requested to contact Tina Kreisher at 1-800-323-5547, ext. 1383 if their TM-300 unit has a serial number that falls in the range listed in the recall letter. Tina will arrange for the unit to be shipped to the manufacturer's authorized repair center for upgrading of the software to version 2.8, and for the shipment of a loaner unit while their unit is being upgraded.

Device

Device Recall Performa TM300 Traction System
  • Modelo / Serial
    Product No. A501-009, serial numbers 1000 through 1207
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide and internationally to Canada, the United Kingdom, Korea, Turkey and Indonesia
  • Descripción del producto
    TM-300 Traction System; an Rx software driven device used for patient traction; Manufactured for Sammons Preston Roylan, An Ability One Company, Bolingbrook, IL 60440, Manufactured by: ITO Co., Ltd., 3-3-3 Toyotama-Minami, Nerima-ku, Tokyo, 176-8605, Japan
  • Manufacturer
    Sammons Preston Rolyan, An Ability One Company

Manufacturer

Sammons Preston Rolyan, An Ability One Company
  • Dirección del fabricante
    Sammons Preston Rolyan, An Ability One Company, 4 Sammons Ct, Bolingbrook IL 60440-4995
  • Source
    USFDA