Events

Retiro De Equipo (Recall) de Device Recall Amsco 3085SP Surgical Table

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 Steris Corporation.

¿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
    54705
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2402-2012
  • Fecha de inicio del evento
    2010-02-17
  • Fecha de publicación del evento
    2012-09-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89058
  • 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, operating-room, ac-powered - Product Code FQO
  • Causa
    Customers may be storing objects on the base and/or around the column of the surgical table. this prohibited practice and misuse known by the customers can damage the override switch assembly located at the top of the column cover. depending upon the nature and severity of the damage to the electronics of the table, it is possible that the table could move without prompting by an operator .
  • Acción
    Steris sent an Urgent Field Correction Notice letter dated February 17, 2010 to their customers. The letter identified the affected product, description of the problem and actions to be taken. Customers were instructed to examine their units for any structural damage. If found they are to discontinue use and arrange for a field representative to visit the facility to assess the damages and arrange for repair of the unit. For information or questions regarding STERIS visit to your facility contact STERIS Field Service Dispatch at 1-800-333-8828.

Device

Device Recall Amsco 3085SP Surgical Table
  • Modelo / Serial
    B420702032 to 0402110097
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico and the following countries: American Samoa, Argentina, Australia, Bahrain, Bangladesh, Bermuda, Brazil, Canada, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Germany, Greece, Guam, Hong Kong, India, Indonesia, Israel, Italy, Japa, Jordan, Kazakhstan, Korea, Kuwait, Lebanon , Libya , Malaysia , Mexico, Morocco, New Zealand, Panama, Peru, Philippines , Poland, Portugal, Qatar, Russia, Saudi Arabia , Singapore, South Africa, Spain, Sri Lanka, Taiwan, Thailand, Trinidad and Tobago, Turkey & United Kingdom.
  • Descripción del producto
    A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. || Product Usage: || Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or specialized surgical procedures. There are movable components and accessories intended for use during diagnostic examinations or surgical procedures to support and position a patient.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Dirección del fabricante
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060
  • Empresa matriz del fabricante (2017)
    Steris Plc
  • Source
    USFDA