Events

Retiro De Equipo (Recall) de Harmony Equipment Management System, Model 603X/80XX, STERIS Corporation, Mentor, OH

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
    66138
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0141-2014
  • Fecha de inicio del evento
    2013-08-15
  • Fecha de publicación del evento
    2013-11-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121539
  • 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
  • Causa
    Dr¿ger medical gmbh has notified steris of the potential for a break in the drive screw contained in the motorized ceiling supply unit, a component of the harmony ems system. the ceiling supply unit controls the motorized adjustment of the height and rotation of the supply column. should a break occur in the drive screw, there is potential for the adjustable arm to drop down, causing the ems sys.
  • Acción
    STERIS sent an Urgent Voluntary Field Correction Notice dated August 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. STERIS action- Drager Medical has provided STERIS instructions for inspection of the alignment of the mounting plate of the motor unit. If it is found that the mounting plate is bent, the drive screw within the motor unit must be replaced. STERIS will visit your facility to inspect the motorized ceiling supply unit of your Harmony EMS system(s) and if damage is observed, will replace the drive screw within the motor unit. For further information or if you have any questions regarding our visit to your facility, please contact STERIS Field Service Dispatch at 1-800-333-8828.

Device

Harmony Equipment Management System, Model 603X/80XX, STERIS Corporation, Mentor, OH
  • Modelo / Serial
    Serial numbers 0422503114 - 0426604096
  • Distribución
    Nationwide distribution: USA including the states of Alabama, Arkansas, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Washington and Wisconsin.
  • Descripción del producto
    Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH || Harmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power and audio/visual data services, in addition to managing surgical support equipment such as endoscopic equipment, cautery devices and insufflators.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Dirección del fabricante
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Empresa matriz del fabricante (2017)
    Steris Corporation
  • Source
    USFDA