Events

Retiro De Equipo (Recall) de Device Recall Spacelabs Smart Disclosure System, Model 92810

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
    63931
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0694-2013
  • Fecha de inicio del evento
    2012-12-05
  • Fecha de publicación del evento
    2013-01-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115067
  • 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
    Displaying or printing of an incorrect waveform for the time indicated in the printout or display in the spacelabs healthcare intesys clinical suite (ics) g2, version 4.03, clinical access portion of smart disclosure, model 92810.
  • Acción
    Spacelabs has sent the Urgent -Medical Device Correction Spacelabs Healthcare ICS G2 Version 4.03 Model 92810 Smart Closure letter, dated 19 December 2012, to all U.S. customers. The firm plans to send a customer letter (translated as necessary) via e-mail to all international subsidiaries and distributors of record on December 27, 2012. The letter is addressed to Hospital Administrator/Biomedical Manager/Office Manager. Users are advised on the following actions: 1) Advise your staff of this potential failure and advise them to always click the "Refresh" button when scrolling to new waveform data prior to printing or viewing waveform information or storing saved events. 2) We will contact you at the earliest possible date to schedule a convenient time for your hospital to upgrade your affected software at no cost. Customers with questions can contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

Device

Device Recall Spacelabs Smart Disclosure System, Model 92810
  • Modelo / Serial
    ICS G2 Smart Disclosure Model 92810, Version 4.03.  There are no serial numbers.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA including Puerto Rico and the states of California, Florida, Iowa, Illinois, Louisiana, Michigan, Minnesota, North Carolina, South Carolina, Texas, and Washington, and the countries of Argentina, Mexico, France, and India.
  • Descripción del producto
    Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. || The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. || The product provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in multiple formats, including a rhythm, a histogram, and a summary view. || Standard reports are available from Smart Disclosure, including saved events, disclosure, trends, histogram, and summary. || The Spacelabs Smart Disclosure System, Model 92810 is indicated for use in clinical situations where there is a need for review of physiological waveform information and alarm events up to 72 hours after the fact. Smart Disclosure is also indicated in those situations where a retrospective analysis of monitoring patients' ECG waveform data, that can be annotated and edited, is desired. The intended use of the Spacelabs Smart Disclosure is to interface with the Spacelabs monitoring network, providing the user with a means of recalling waveform information and performing retrospective analysis. The most recent 72 hours of monitored patient ECG waveform data can be analyzed, with each analysis limited to 24 hours or less.
  • 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