Devices

Device Recall STRYKER NAVIGATION SYSTEM iNtellect Cranial Software

Model / Serial
Verisions 1.0 and 1.1; all batches: GC400F3001; GC700F3001; GCN00F3002; GCU00F3002; GCV00F3002; H1800F3002; H1P00F3002; H1Q00F3002; H1V00F3002; H2600F3002; H2M00F3002; H2P00F3003; H3800F3003; H3D00F3003; H3G00F3003; H3T00F3003; H3U00F3003; H4C00F3003; H4Q00F3003; H5300F3003; H5800F3003; H6500F3003; H6600F3003; H6B00F3003; H6N00F3003; H7400F3003; H7R00F3003; H7X00F3003; H8700F3003; H9U00F3003; H9V00F3003; HA500F3003; HAH00F3003; HBF00F3003; HBL00F3003; HBN00F3003; HBU00F3003; HBW00F3003; HC300F3003; and HC600F3003.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
Product Description
Stryker Navigation System - iNtellect Cranial Software, Part number 6000-650-000. || 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
Stryker Instruments Division of Stryker Corporation
1 Event
- Recall of Device Recall STRYKER NAVIGATION SYSTEM iNtellect Cranial Software

Manufacturer

Stryker Instruments Division of Stryker Corporation

Manufacturer Address
Stryker Instruments Division of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

3 devices with a similar name

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Device Recall STRYKER NAVIGATION SYSTEM iNtellect Cranial Software

Model / Serial
Verisions 1.0 and 1.1; all batches: HCE00F3002; HCL00F3002; J2J00F3002; J2L00F3002; J3500F3002; J3K00F3002; J3T00F3002; J4100F3002; J4900F3002; J5500F3002; J5600F3002; J6500F3002; J6C00F3002; J7A00F3002; J8100F3002; J8C00F3002; J8S00F3002; J9300F3002; J9900F3002; JA600F3002; JBJ00F3002; JBT00F3002; JC100F3002; JCK00F3002; JCV00F3002; JCW00F3002; K1700F3002; K3400F3002; K3G00F3003; K3K00F3003; K3X00F3003; K4H00F3003; K5800F3003; K5L00F3003; K6A00F3003; K6F00F3003; K6W00F3003; K7200F3003; K7600F3003; K7900F3003; K8700F3003; K8A00F3003; K8T00F3003; K9200F3003; K9E00F3003; K9P00F3003; K9W00F3003; KA100F3003; KAE00F3003; KAP00F3003; KAT00F3003; KB500F3003; KBT00F3003; KC400F3003; KCG00F3003; KCX00F3003; L1B00F3003; L1E00F3003; L1K00F3003; L2800F3003; L3100F3003; L3B00F3003; L3G00F3003; L3S00F3003; L4700F3003; L5A00F3003; L5J00F3003; L6N00F3003; L6U00F3003; L7500F3003; L7K00F3003; L8P00F3003; L9P00F3003; LA500F3003; LAB00F3003; and LAD00F3003.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
Product Description
Stryker Navigation System - iNtellect Cranial Software, Part number 6000-651-000. 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
Stryker Instruments Division of Stryker Corporation

Device Recall STRYKER NAVIGATION SYSTEM iNtellect Cranial Software Upgrade

Model / Serial
verisions 1.0 and 1.1; all batches: HCU00F3002; J1800F3002; J1B00F3002; J1H00F3002; J1R00F3002; J2400F3002; J2K00F3002; J2U00F3002; J4E00F3002; and K4100F3003
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
Product Description
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
Stryker Instruments Division of Stryker Corporation

Device Recall STRYKER NAVIGATION SYSTEM iNtellect Cranial Software Maintenance

Model / Serial
Verisions 1.0 and 1.1; all batches: HCE00F3002; J1A00F3002; and J2K00F3002
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
Product Description
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
Stryker Instruments Division of Stryker Corporation

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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