Retiro De Equipo (Recall) de Device Recall STRYKER NAVIGATION SYSTEM iNtellect Cranial Software Maintenance

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 Stryker Instruments Division of Stryker Corporation.

¿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
    57487
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1406-2011
  • Fecha de inicio del evento
    2010-11-10
  • Fecha de publicación del evento
    2011-02-25
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2011-06-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Neurological Stereotaxic Instrument - Product Code HAW
  • Causa
    When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. this may lead to insufficient or inaccurate correlation results or incorrectly shown orientation of every second image series during navigation.
  • Acción
    Urgent: Medical Device Recall Notification letters were sent on 12/3/2010, and software upgrades were to be performed in the field by the end of 2010. Specific Customer Instructions: 1) Locate the units listed in the notification. 2) Distribute this notification to all departments affected. 3) Return the enclosed business reply form to confirm receipt of this notification and identify how many affected units are currently in your inventory. 4) Once the new software is available, Stryker will dispatch a service tech in order to update the software. Note: Software upgrades for all applications will be available by the end of the year. The upgrades will be scheduled as we receive your business reply form. Note: If you currently have a Time License or Pay Per Use card, a new one will be issued to you at the time of the update. 5) If you have loaned or sold any of the units listed in this notification, please, forward a copy of this notice to the new users and advise Stryker of the new users name and their new location. 6) If you have disposed of any of the affected units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial numbers. Questions regarding this recall should be directed to Stryker Field Action Team at 800-800-4236, ext 3808, 3584, or 4354 between the hours of 8 a.m. - 5 p.m. Monday - Friday.

Device

  • Modelo / Serial
    Verisions 1.0 and 1.1; all batches: HCE00F3002; J1A00F3002; and J2K00F3002
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
  • Descripción del producto
    Stryker Navigation System - iNtellect Cranial Software - Maintenance, Part number 6000-651-200. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Stryker Instruments Division of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA