Events

Retiro De Equipo (Recall) de Device Recall BD MAX 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 BD LIFE SCIENCES.

¿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
    76900
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1864-2017
  • Fecha de inicio del evento
    2015-07-29
  • Fecha de publicación del evento
    2017-04-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154530
  • 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
    Software, transmission and storage, patient data - Product Code NSX
  • Causa
    The bd max system software version 4.44a contains a software anomaly that has the potential to affect some open system reagent (osr) customers utilizing user defined protocol (udp) assays. customers utilizing only ivd assays are not affected. this anomaly may cause the osr customer system to incorrectly switch the columns of the truth table on the users display. if the user tries to fix their display data, the display will appear correct however, the database may become incorrect, potentially resulting in incorrect results reporting. bd is able to trace the issue to a limited number of instruments that have software version 4.44a installed. note that the problem only affects customers that are either creating a new udp with result logic or modifying the result logic of an existing udp.
  • Acción
    BD sent an Urgent Field Corrective Action Recall notification was initiated on July 29, 2015. The customer was initially contacted via a phone call and subsequently provided with a written communication. All US customers were contacted directly by phone and provided the written communication. Global holds were placed on July 21, 2015 and July 24, 2015. For further questions, please call (410) 316-4000.

Device

Device Recall BD MAX System
  • Modelo / Serial
    Catalog number 441916
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to the states of : CA, CO, FL, IL, MN, MO, MT, NE, NJ, NY, OH, OR, PA, TX, TN, WA, WI., and to the countries of : Canada, Hong Kong, Taiwan, Turkey and Europe. Federal Government Agency sales/distribution centers or foreign countries VA Fort Harrison and VAMC Austin.
  • Descripción del producto
    Software version 4.44A utilized on the BD MAX System
  • Manufacturer
    BD LIFE SCIENCES

Manufacturer

BD LIFE SCIENCES
  • Dirección del fabricante
    BD LIFE SCIENCES, 54 Loveton Cir, Sparks Glencoe MD 21152-9202
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA