Events

Retiro De Equipo (Recall) de Device Recall Arial WaterResistant Pendant, model 59350

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
    76047
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1499-2017
  • Fecha de inicio del evento
    2016-06-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-11-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152047
  • 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
    System, communication, powered - Product Code ILQ
  • Causa
    Devices were incorrectly programmed during manufacturing therefore depressing the pendant button may result in an alarm not sounding as intended.
  • Acción
    Stanley Healthcare sent an Important Recall Notice dated June 22, 2016, to all affected customers. The notice instructed customers to discontinue use of the device and to contact the recalling firm to arrange for return of the device. The recalling firm also asked the customer to complete a response form indicating they read, understood and complied with the recall notice. Customers with questions were instructed to contact Arial Customer Service at 888-716-0077. For questions regarding this recall call 781-216-9035.

Device

Device Recall Arial WaterResistant Pendant, model 59350
  • Modelo / Serial
    Serial numbers WP149149 through WP149398 and WP149649 through WP149898.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to AR, AZ, CA, FL, GA, IA, ID, IN, KS, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SD, UT, VA, and WI.
  • Descripción del producto
    Arial Wireless Water-Resistant Call Pendant || The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button.
  • Manufacturer
    Stanley Security Solutions Inc

Manufacturer

Stanley Security Solutions Inc
  • Dirección del fabricante
    Stanley Security Solutions Inc, 4600 Vine St, Lincoln NE 68503-2823
  • Source
    USFDA