Device Recall STRYKER NAVIGATION SYSTEM iNtellect Cranial Software Upgrade

  • Modelo / Serial
    verisions 1.0 and 1.1; all batches: HCU00F3002; J1800F3002; J1B00F3002; J1H00F3002; J1R00F3002; J2400F3002; J2K00F3002; J2U00F3002; J4E00F3002; and K4100F3003
  • 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 - Upgrade, Part number 6000-651-100. 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
  • 1 Event

Fabricante

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