Events

Retiro De Equipo (Recall) de Horizon Cardiology Hemo Component Schiller Argus Pro PB1000 Monitor unit

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 McKesson Provider Technologies - Medical Imaging Group.

¿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
    55598
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1974-2010
  • Fecha de inicio del evento
    2010-04-15
  • Fecha de publicación del evento
    2010-07-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-07-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91258
  • 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
    computer, diagnostic, programmable - Product Code DQK
  • Causa
    Mckesson has recently discovered that certain horizon cardiology hemo systems were running specific schiller argus-pro pb 1000 firmware versions that might cause a delay in the display of physiological parameters on the horizon cariology hemo real time monitor screen.
  • Acción
    The firm, McKesson, sent an "Advisory Notice" letter dated April 15, 2010, to all customers. The letter describes the problem, products affected, and actions to be taken by customers. The customers were instructed not to use the Emergency Replacement Hemo kit until they receive a replacement Schiller Argus Pro PB-1000 and they have contacted McKesson Support department at 1-866-777-0202. If you have any questions regarding this notice, please call our Customer Support department at 1-0866-777-0202 and ask to speak to your support Manager.

Device

Horizon Cardiology Hemo Component Schiller Argus Pro PB1000 Monitor unit
  • Modelo / Serial
    Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M Serial numbers prefaced with PB-1000: 765.001471, 760.001566, 760.001793, 760.001882, 760.001920, 760.001934, 760.001970, 760.002043, 760.002113, 765.001168, 765.001307, 765.001520, 765.001553, 765.001599, 765.001609, 765.001510, 765.001632, 765.00165, 765.003014, 760.001320, 760,001552, 760.001555, 760,001920, 760.002107, 765.001224, 765.001306, 765.001608.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: CA, CO, MD, NH, NT, NY, TN, and TX .
  • Descripción del producto
    Horizon Cardiology Hemo Component Schiller Argus Pro PB-1000 Monitor unit. || Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M. || A programmable diagnostic computer intended for acquiring, digitizing, storing, displaying and reviewing hemodynamic data for use in hospital cardiac catheterization laboratories. The system is cleared for us with a component physiological data collection unit - the Schiller Argus Pro PB 1000 Monitor unit.
  • Manufacturer
    McKesson Provider Technologies - Medical Imaging Group

Manufacturer

McKesson Provider Technologies - Medical Imaging Group
  • Dirección del fabricante
    McKesson Provider Technologies - Medical Imaging Group, 1639 State Rt 10 Ste 100, Parsippany NJ 07054-4506
  • Empresa matriz del fabricante (2017)
    Mckesson Corporation
  • Source
    USFDA