Events

Retiro De Equipo (Recall) de Device Recall CIVCO Posifix Extension

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
    55999
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0396-2011
  • Fecha de inicio del evento
    2010-06-21
  • Fecha de publicación del evento
    2010-11-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92400
  • 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
    Under certain conditions, the extensions can become detached from the main body of the couch.
  • Acción
    The recalling firm, CIVCO, issued an 'Urgent Field Safety Notice" dated June 15, 2010, via overnight mail on June 21, 2010, regarding the first issue for the three extension models. The letter described the product, problem, and actions to be taken by the customers. The customers were instructed to load the patients on the couch from the bottom of the couch and not from the superior end with the extension and do not let patients crawl to the top of the couch with their full upper body weight at the end of the couch; notify others within their organization that may have the extension, and complete and return the enclosed response form via fax: Attention: CIVCO MTL6600 Rectangular Extension at 877-271-2310. The letter informs the customer that they will be receiving a kit to replace the locking tab so that the extension will be less likely to come loose. Once the kit is received, the customers are ask to return the replaced part and sign a confirmation form for their records. CIVCO sent a second "Urgent Field Safety Notice" dated July 20, 2010 via overnight mail on July 21, 2010, and by phone on July 22, 2010, regarding the second issue which covered only MTIL6600 regarding the weight being dropped onto the corner of the rectangular extension. The letter described the product, problem and action to be taken by the customers. The customers were instructed to accept a one-piece Universal Couch Top replacement; sign the attached form stating the they will stop using the rectangular extension and return it to CIVCO or sign the form stating they have been advised of the recall and they will exercise the necessary precautions to prevent the event from occurring by always using the thumb screw lock and never allowing the patient to crawl on the couch top or extension, and to notify others within their organization that have the extension. The customer was informed that their current system would be replaced and sent back to the recalling firm. Please contac

Device

Device Recall CIVCO Posifix Extension
  • Modelo / Serial
    Lots M168340 and M167490
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including states of: CA, FL, IA OH, and WI; and countires of: United Kingdom, Australia, and Switzerland.
  • Descripción del producto
    CIVCO Posifix Extension, REF MTIL6606, Reusable non-sterile extension for use with the Universal Couchtop. The firm name on the label is CIVCO, Orange City, IA. || For use to support and aid in positioning a patient during radiologic and other medical procedures.
  • Manufacturer
    Med Tec Inc

Manufacturer

Med Tec Inc
  • Dirección del fabricante
    Med Tec Inc, 1401 8th St, PO Box 320, Orange City IA 51041-0320
  • Empresa matriz del fabricante (2017)
    Roper Technologies Inc
  • Source
    USFDA