Events

Retiro De Equipo (Recall) de Device Recall Tabs Professional Monitor, Model 25023

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
    61796
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2489-2012
  • Fecha de inicio del evento
    2012-05-04
  • Fecha de publicación del evento
    2012-09-28
  • 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=109109
  • 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
    The monitor may fail to sound an alarm.
  • Acción
    Stanley Security Solutions, Inc. sent an Important Recall Notice dated May 4, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease using any of the affected product. The customers were informed, however, that they may continue to use the units as long as they were powered with a 9-volt alkaline battery in accordance with current instructions because the issue only occurs when using the 12V DC adaptor. The letter also informs the consignee to expect a follow-up notice no later than 6/1/12 that will provide additional instructions. The recalling firm issued additional letters dated 6/5/12 to distributors and end users with updated instructions. The letter informed them further testing revealed the possibility that a subset of affected monitors may also fail to alarm when powered by a 9V battery if weight is rapidly applied and removed from the pressure pad. Therefore, the recalling firm decided to recall and repair this subset of affected monitors and provided the serial number ranges that must be returned for repair. The letter also provided a list of serial number ranges that could be corrected in the field by permanently blocking access to the 12V DC jack on the monitor. Instructions were enclosed to show the customer how to disable to the jack. In addition the distributor letters request the customer to provide the recall information to their downstream customers. A response form was included to report the amount of affected product in the customers' inventory. For questions customers were instructed to call 888-224-2460. For questions regarding this recall call 407-271-2097.

Device

Device Recall Tabs Professional Monitor, Model 25023
  • Modelo / Serial
    Serial numbers 236662 thru 265692
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Canada and Great Britain.
  • Descripción del producto
    Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Security Solutions, Inc., Lincoln, NE. || Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
  • 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