Events

Retiro De Equipo (Recall) de Device Recall Spacelabs Medical Xprezzon Bedside Monitor, Model 91393

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 Spacelabs Healthcare, Llc.

¿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
    62437
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2019-2012
  • Fecha de inicio del evento
    2012-06-12
  • Fecha de publicación del evento
    2012-07-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110571
  • 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, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Causa
    There were reports that a certain combination of key presses will cause the module to disconnect from the xprezzon bedside monitor, model 91393, and the patient parameters will drop from the display. the parameters return after power cycling the monitor.
  • Acción
    Spacelabs Healthcare sent an Urgent Medical Device Correction letter dated June 29 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 advise their staff of the potential failure of the XPREZZON Bedside Monitor. Spacelabs will contact customers to schedule a convenient time for their hospital to upgrade their affected monitors, at no cost. On July 6 2012, a customer letter (translated as necessary) URGENT - MEDICAL DEVICE CORRECTION Spacelabs Healthcare XPREZZON Bedside Monitor will be emailed to all international subsidiaries and distributors of record. Customers with questions can contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support. For questions regarding this recall call 800-522-7025, ext 2.

Device

Device Recall Spacelabs Medical Xprezzon Bedside Monitor, Model 91393
  • Modelo / Serial
    040-1632-00; 1393-000013; 1393-000039; 1393-000040; 1393-000041; 1393-000341; 1393-000382; 1393-000383; 1393-000384; 1393-000385; 1393-000386; 1393-000387; 1393-000388; 1393-000808; 1393-000831; 1393-001374; 1393-001375; 1393-001453; 1393-001990; 1393-001991; and 1393-001992.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including Florida, Iowa, Oklahoma, South Caroline and the countries of India, Germany and Panama.
  • Descripción del producto
    Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. || The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other devices via Flexport interfaces. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Spacelabs Healthcare Xprezzon Bedside Monitor may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitor allows network based applications to open windows and display information the Xprezzon and other networked monitors. The Spacelabs Healthcare Xprezzon Bedside Monitor is designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Xprezzon Bedside Monitors is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.
  • Manufacturer
    Spacelabs Healthcare, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • Dirección del fabricante
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Empresa matriz del fabricante (2017)
    OSI Systems Inc
  • Source
    USFDA