Events

Retiro De Equipo (Recall) de Device Recall Ultraview Universal Clinical Workstation (UCW) Model 90385

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 Medical Incorporated.

¿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
    30797
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0422-05
  • Fecha de inicio del evento
    2005-01-07
  • Fecha de publicación del evento
    2005-01-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36615
  • 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
    Display, Cathode-Ray Tube, Medical - Product Code DXJ
  • Causa
    Weakness of the swivel base for the universal clinical workstation may result in the unit falling from its mounted position endangering users and patients.
  • Acción
    All US customers were sent a Medical Device Recall letter on 1/7/2005 describing how to examine monitors for the defect and to discontinue use of any suspect unit s until examintaion by a Field Service Engineer . International customers will be notified via email or letter on 1/14/2005. Follow up contact by Customer Support and Global Support is planned for any customer not responding with a FAX-back form.

Device

Device Recall Ultraview Universal Clinical Workstation (UCW) Model 90385
  • Modelo / Serial
    Universal Ultraview Clinical Workstation Model 90385 base versions with Revision M or earlier. This recall involves certain units within the serial number range SN: 385-000337 to SN: 385-111440. The firm indicated that not all serial numbers within this range are affected by this recall, but only those units with the specified Revision M or earlier base which have not already been updated.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The firm completed a survey of their customer records and determined a total of 12,306 units were installed from January of 1994 through December of 1997. 7,601 units were originally sold to 767 US accounts and 4,705 units were sold to 102 international accounts. The firm estimates approximately 3000 units worldwide are still in operation with the Revision M or earlier base.
  • Descripción del producto
    Ultraview Universal Clinical Workstation System Model 90385.
  • Manufacturer
    Spacelabs Medical Incorporated

Manufacturer

Spacelabs Medical Incorporated
  • Dirección del fabricante
    Spacelabs Medical Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA