Events

Retiro De Equipo (Recall) de Device Recall CIVCO SBRT System, REF MTSBRT001,

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
    57543
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3020-2011
  • Fecha de inicio del evento
    2010-12-30
  • Fecha de publicación del evento
    2011-08-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96699
  • 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
    Table, radiographic, stationary top - Product Code IXQ
  • Causa
    Systems sold before december 2009 displayed a scale of 0-40cm going from left to right, while systems after december 2009 reversed this and were displayed as 40-0cm from left to right.
  • Acción
    CIVCO issued a "FIELD SAFETY NOTIFICATION" letter dated 12/20/2010 beginning 12/30/2010, via FedEx or UPS to distributors and customers. The notification identifies the affected device, problem, and field safety corrective action. The letter states that if customers have more than one system purchased from different time periods that they should examine their systems and assess if there is any mismatch. The recalling firm will rework the system to correct the difference and send it back to the customer. To take advantage of this correction customers are advised to contact the recalling firm within thirty days of receiving the safety notification. The letter includes a response form to be completed and returned as per instructions, to indicate that the notice has been read and understood by all operators of the equipment. The letter to distributors requested that a copy of the notification letter be forward to all customers who have received this component. For assistance contact your CIVCO insides sales representative by calling CIVCO Medical Solutions, Radiation Oncology, at 800-842-8688.

Device

Device Recall CIVCO SBRT System, REF MTSBRT001,
  • Modelo / Serial
    M061240, M061420, M064140, M064150, M064160, M064170, M064180, M064190, M064200, M064210, M064220, M064230, M070640, M070650, M070660, M072030, M104700, M104710, M104720, M104740, M110410, M110420, M110450, M110460, M115610, M128630, M128660, M128680, M128690, M137590, M148640, M148660, M148690, M148700, M165740, M177850, M177880, M226800, M226810, M226820, M226830, M226840, M239320, M239330 and M256660
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA ( nationwide) including the state of PA. and countries of: Canada, China, England, Israel, Italy, Japan, Korea, The Netherlands, Russia, Spain, Sweden, Switzerland and Turkey.
  • Descripción del producto
    CIVCO SBRT System, REF MTSBRT001, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa || Product Usage: The recalled product is intended to support and aid in positioning a patient during radiologic and other medical procedures.
  • 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