Events

Retiro De Equipo (Recall) de Device Recall Spacelabs Healthcare Qube Compact Monitor

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 Inc.

¿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
    68491
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1852-2014
  • Fecha de inicio del evento
    2014-06-06
  • Fecha de publicación del evento
    2014-06-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128034
  • 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
    Spacelabs healthcare is recalling qube compact monitor, model 91390, due to a potential chance of losing network connection after switching from hardwired ethernet connection to using the qube docking station without powering down the device. the bedside monitor and all of its alarms will continue to function normally. no one has been injured as a result of this issue.
  • Acción
    Spacelabs Healthcare Snoqualmie, WA sent an Urgent Medical Device Correction letter, dated June 6, 2014, to all consignees. The letter identified the product, the problem, and the actions to be taken by the customer. The letter instructed customers using docking station ready qube monitors with qube docking stations immediately advise their staff of this situation; and, to follow the steps provided, if they continue to use a docking station ready qube monitor with a docking station. Spacelabs Healthcare will contact customers at the earliest possible date to schedule a convenient time for Spacelabs to correct customer's affected qube monitors at no cost. Questions should be directed to Spacelabs Healthcare Technical Support at 1-800-522-7025.

Device

Device Recall Spacelabs Healthcare Qube Compact Monitor
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY; and, the countries of AFG,ARE, ARG, AUS, BHR, BOL, CAN, CHE, CHL, CHN, COL, CRI, DEU, DOM, ECU, FRA, GBR, IND, ITA, JOR, KWT, LBY, MYS, NLD, OMN, PAN, POL, PRT, ROU, SAU, SGP, THA, TTO, TUN, TUR, TWN, and VNM.
  • Descripción del producto
    Spacelabs Healthcare Qube Compact Monitor, Model 91390. || Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces.
  • Manufacturer
    Spacelabs Healthcare Inc

Manufacturer

Spacelabs Healthcare Inc
  • Dirección del fabricante
    Spacelabs Healthcare Inc, 35301 SE Center St, Snoqualmie WA 98065-9216
  • Empresa matriz del fabricante (2017)
    OSI Systems Inc
  • Source
    USFDA