Events

Retiro De Equipo (Recall) de Harmony Insight Diagnostic Monitor Support System

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
    75385
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0746-2017
  • Fecha de inicio del evento
    2016-10-05
  • Fecha de publicación del evento
    2016-12-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150180
  • 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
    Lamp, surgical - Product Code FTD
  • Causa
    The drager pendula spring arm device has a set of screws located on the spring arm that were not properly secured with loctite and may become loose.
  • Acción
    Steris sent an Urgent Voluntary Field Correction Notice to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remind staff personnel that Harmony Insight Diagnostic Monitor Support Systems, including the affected Drager Pendula spring arms, are not designed or intended to be placed over hospital personnel or patients and should be moved with care. Customers with questions were instructed to call 440-392-7358 or Steris Customer Service at 1-800-548-4873. For questions regarding this recall call 440-392-7231.

Device

Harmony Insight Diagnostic Monitor Support System
  • Modelo / Serial
    0419016160 0421416123 0420816119 0415216095 0409016039 0409016038 0404716127 0434815015 0429915001 0429915002 0418015066 0418015065 0416815002 0416015002 0416015001 0413515012 0409615011 0407615001 0407615002 0405015102 0429614003 0401515015 0431714001 0430914002 0430914001 0427614022 0428014006 0423914014 0421714007 0416814001 0415014002 0414314082 0413914001 0412714043 0411414001 0411414003 0411414002 0411114001 0401614001 0404814128 0405014014 0403814116 0402214076 0401314131 0401514013 0400614027 0434413019 0433813017 0429113164 0430113149 0427313064 0417013083 0414813001 0412113002 0412113001 0410013001 0405213038 0404413018 0404413017 0404413016 0404413016 0436112019 0436112018 0434912001
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AK, AZ, CA, CO, FL, IL, KY, MI, MO, NB, NJ, NY, OH, PA, RI, SD, TN, TX, UT, WA & WV.
  • Descripción del producto
    Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) || The system is intended for use in surgical operating rooms (OR) or intraoperative surgical/imaging rooms where simultaneous multiple image viewing is required
  • 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