Device Recall STRYKER NAVIGATION SYSTEM iNtellect Cranial Planning Software

Verisions 1.0 and 1.1; all batches: H2200F3002; H3D00F3003; H7900F3003; H7P00F3003; H9U00F3003; and HC400F3003.

Neurological Devices

2

No

Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.

Stryker Navigation System - iNtellect Cranial Navigation/Planning Software, Part number 6000-650-100. 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.

Verisions 1.0 and 1.1; all batch J3H00F3002

Neurological Devices

2

No

Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.

Stryker Navigation System - iNtellect Cranial Planning Software - Enable, Part number 6000-652-300. 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.