Device Recall STRYKER NAVIGATION SYSTEM iNtellect Cranial Software Maintenance

  • 모델명 / 제조번호(시리얼번호)
    Verisions 1.0 and 1.1; all batches: HCE00F3002; J1A00F3002; and J2K00F3002
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
  • 제품 설명
    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
  • 1 Event

제조사

  • 제조사 주소
    Stryker Instruments Division of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
  • 제조사 모회사 (2017)
  • Source
    USFDA