Events

Retiro De Equipo (Recall) de Device Recall MicroTech Informer Plus Silver Monitors

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 Stanley Security Solutions, Inc..

¿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
    60698
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1476-2012
  • Fecha de inicio del evento
    2011-12-13
  • Fecha de publicación del evento
    2012-04-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106247
  • 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
    Monitor, bed patient - Product Code KMI
  • Causa
    Connection between the call cord and the receptacle may not make a correct connection resulting in a continuous or intermittent (false) signal to the nurse call system.
  • Acción
    Stanley Healthcare Solutions, Inc. contacted affected customers via phone and email on December 13, 2011. A follow-up certified letter was sent on December 14, 2011. Customers were additionally sent and "Important Recall Notice letter on December 16, 2011 after errors in the original letters were detected. The letter identified the affected product, problem, actions to be taken, and included a reply form for the customer to complete and return. The recalling firm requested their customers to stop using the monitor and contact them for return of the unit. Contact information (phone, fax, & email) was included. For question contact Micro-Tech Customer Service at 1-800-206-1045.

Device

Device Recall MicroTech Informer Plus Silver Monitors
  • Modelo / Serial
    Serial numbers 071100025 through 111100306
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide including the states of CT, FL, KY, MN, NC, NE, NH, NJ, NY, PA, TX and the country of Canada (5 units).
  • Descripción del producto
    Micro-Tech Informer Plus Silver Monitor, Model 81830. The firm name on the label is Stanley Security Solutions, Inc., Lincoln, NE. || Product Usage: || The system is a bed exit system designed to indicate, by alarm or signal, when someone attempts to leave the bed. The system consists of a control unit that is mounted on the bed and a pressure sensitive bed sensor pad that is placed across the width of the bed under the mattress or just beneath the sheets and overlays. The control unit is powered by means of a plug-in type power supply and an alarm cord is used to interface the control unit with the nurse call system.
  • Manufacturer
    Stanley Security Solutions, Inc.

Manufacturer

Stanley Security Solutions, Inc.
  • Dirección del fabricante
    Stanley Security Solutions, Inc., 4600 Vine St, Lincoln NE 68503-2823
  • Empresa matriz del fabricante (2017)
    Stanley Black & Decker Inc.
  • Source
    USFDA