Events

Retiro De Equipo (Recall) de MAQUET YUNO OTN Mobile Operating Table and Extension Device

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 Maquet Cardiovascular Us Sales, Llc.

¿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
    65159
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1622-2013
  • Fecha de inicio del evento
    2013-04-26
  • Fecha de publicación del evento
    2013-07-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118049
  • 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, examination, medical, powered - Product Code LGX
  • Causa
    Maquet has identified a potential issue with the extension device handle (part number 1433.62a1) and will make enhancements to the yuno table (part number 1433.01f0). identification of the extension device issue: by fully actuating the lever of the extension device handle, the operator's skin can enter a gap between the handle lever and a recess in the handle bar. when the lever is released,.
  • Acción
    MAQUET Getinge Group issued an Urgent Medical Device Recall letter/"Field Action Response Form dated April 26, 2013, via Federal Express to all affected customers. The recall notification identifies the product, issue with the product, and measures to be taken by the user. Customers were instructed that the firm would contact them to arrange for a loaner YUNO table and extension device while the table and extension device are upgraded. Upon completion of the upgrades, MAQUET would reinstall their upgraded YUNO table and extension device and remove the loaner device. Customers were instructed to complete and return the enclosed Field Action Response Form, acknowledging their receipt and understanding of the communication by e-mailing a scanned copy to FieldAction@maquet.com or via fax at 973-807-1658. Customers with questions were instructed to contact their MAQUET representative or MAQUET Technical Support at 888-627-8383, option 3, followed by option 1. For questions regarding this recall call 973-709-7691.

Device

MAQUET YUNO OTN Mobile Operating Table and Extension Device
  • Modelo / Serial
    YUNO OTN Mobile Operating Table: 1433.01F0 Extension Device: 1433.62A1
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including Arizona, Georgia, North Dakota, South Carolina, Texas and Tennessee, Internationally to United Arab Emirates, Austria, Brazil, Canada, Switzerland, China, Germany, Spain, France, United Kingdom, Italy, Japan, Singapore, Thailand, Turkey, Serbia, and South Africa.
  • Descripción del producto
    MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. || The YUNO OTN is used to support and position patients for surgical procedures immediately before, during and after the surgical phase. The table top is radio translucent and enables intraoperative use of X-ray equipment.
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • Dirección del fabricante
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA