Retiro De Equipo (Recall) de Device Recall Claymount Harmony2 Bucky

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 Claymount Assembli.

¿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
    67715
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1836-2014
  • Fecha de inicio del evento
    2014-03-15
  • Fecha de publicación del evento
    2014-06-30
  • Estado del evento
    Completed
  • País del evento
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Holder, radiographic cassette, wall-mounted - Product Code IXY
  • Causa
    Claymount assemblies bv is recalling the harmony2 model of harmony bucky because 1) the devices are incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21 cfr subchapter j, and 2) the device's insulation values do not comply with iec 60601-1 in all cases.
  • Acción
    MEDICAL DEVICE RECALL letters dated March 15, 2014 were sent to all direct accounts. The letters includes instructions to: 1) complete and return the Acknowledgement and Receipt Form accompanying the letter; 2) replace the Harmony2 Bucky(s) with new Harmony3 Bucky(s) that the direct account will be receiving in the near future; 3) if the direct account is a distributor and/or installer and it elects to have their customer(s) perform the replacement, the customer(s) should be provided with a copy of the letter, the replacement Harmony3 Bucky(s), and the replacement notification card, or the direct account can provide the names and addresses of their customers in which case Claymount will contact the customers directly; and, 4) once each unit is replaced, the replacement completion notification card should be mailed or faxed to the Claymount USA office and the Harmony2 Bucky(s) should be returned to "Claymount Americas Corp., ATTN: Alice Packard, 2545 Curtiss St., Downers Grove, IL 60515-4059" or faxed to 630-271-9995. For questions customers were instructed to call the following numbers: USA (630) 271-9729 EUR +31 315 659 150

Device

  • Modelo / Serial
    *** US Devices Only ***   1) Part ID: 17360; Serial Numbers: WO186722/E-1 , WO196470/E-1 , WO198534/E-1.   2) Part ID: 17361; Serial Numbers: WO186723/E-1.   3) Part ID: 17362; Serial Numbers: WO186724/E-1 , WO196360/E-1 , WO198545/E-2.   4) Part ID: 18476; Serial Numbers: WO196188/E-1 , WO196188/E-2 , WO196189/E-2.   5) Part ID: 18477; Serial Numbers: WO198547/E-1.   6) Part ID: 18479; Serial Numbers: WO198552/E-1.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including NC, OH, CO, CA, NJ, IL, OH, PA, FL and Internationally to Canada, China, France, Italy, Netherlands, South Africa, Switzerland, Turkey, and United Kingdom.
  • Descripción del producto
    The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table. It is intended to be used in general radiographic applications as a component of a radiographic system.
  • Manufacturer

Manufacturer