Events

Retiro De Equipo (Recall) de Device Recall Capnostream20

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 Oridion Medical 1987 Ltd..

¿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
    52959
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2232-2009
  • Fecha de inicio del evento
    2009-06-30
  • Fecha de publicación del evento
    2009-09-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84332
  • 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
    ventilator monitor - Product Code CCK
  • Causa
    1) the monitor's ability to withstand electrostatic discharge (esd) to exposed metal connectors on the back of the monitor which may cause the monitor's display to freeze. 2) the unit generates electromagnetic radiation above the limits set by applicable standards for medical devices.
  • Acción
    Oridian sent a letter to all its distributors June 25, 2009, instructing them to gather all the units to be exchanged for factory reconditioned units that have the hardware and software enhancements and meet all performance requirements in full.

Device

Device Recall Capnostream20
  • Modelo / Serial
    Software version V 3.0 and earlier.   Part Number Part Description   CS08651, Capnostream20 with Nellcor pulse oximetry module   CS08653 Capnostream20 with Masimo pulse oximetry module   CS08657 Capnostream20 with Nellcor pulse oximetry module and printer   CS08659  Capnostream20 with Masimo pulse oximetry module and printer
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide.
  • Descripción del producto
    Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbers CS 08651, CS 08653, CS08657, and CS08659.
  • Manufacturer
    Oridion Medical 1987 Ltd.

Manufacturer

Oridion Medical 1987 Ltd.
  • Dirección del fabricante
    Oridion Medical 1987 Ltd., 7 Hamarpe St., P.O. Box 45025, Har Hotzvim Industrial Park, Jerusalem Israel
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA