Events

Retiro De Equipo (Recall) de CIVCO Arm Support

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 Med Tec 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
    77874
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3083-2017
  • Fecha de inicio del evento
    2017-08-10
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158116
  • 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
    Cradle, patient, radiologic - Product Code KXH
  • Causa
    Rigid arm supports (pn: 106015 and 106047), which were used as part of the posiboard-2 and posirest, and were distributed as pn: 106015, 106047, 106521, 106522, 109030, and 109040 between ocotober 2009 and july 2012 may have a height difference of approximately 17mm.
  • Acción
    CIVCO sent an Urgent: Field Action Notice- Customer Communication letter dated July 20th, 2017. The field action notification letter was sent on August 10, 2017, by email requesting the consignee review their inventory and contact their sales representative for product replacement. Enclosed please find a notification letter which is required to be sent to all customers who received this product. Please contact your Insides Sales Representative concerning replacement instructions if you have any questions. You may reach your representative by calling CIVCO Radiotherapy, at 712-737-8688 between 8:00AM and 5:00PM CST. For further question, please call (319) 248-6537.

Device

CIVCO Arm Support
  • Modelo / Serial
    Codes: M181690, M194500, M203470, M213330, M216050, M142180, M143110, M149600, 0154710, M158550, M165330, M16900, M169330, M142230, M149650, M236810
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to the states of : MI, IL and TX., and to the countries of : Greece, Australia, Czech Republic, Hungary, Norway, Brazil, Italy, Switzerland ,UK, Austria, Slovenia, Croatia, Poland, Germany, Japan, France, Netherland, Sri Lanka, Pakistan, Bangladesh, and Israel
  • Descripción del producto
    CIVCO Arm Support, REF 106047, distributed as: || (a) Rigid Arm Support, Large, Set, Red (PN: 106047) || (b) PB2-BDLRL (PN: 109040) || (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) || (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) || The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.
  • Manufacturer
    Med Tec Inc

Manufacturer

Med Tec Inc
  • Dirección del fabricante
    Med Tec Inc, PO Box 320, 1401 8th St SE, Orange City IA 51041-7463
  • Empresa matriz del fabricante (2017)
    Roper Technologies Inc
  • Source
    USFDA