Devices

Device Recall STRYKER NAVIGATION SYSTEM iNtellect Cranial Software

  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
  • Description du dispositif
    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
  • 1 Event

Fabricant

Stryker Instruments Division of Stryker Corporation
  • Adresse du fabricant
    Stryker Instruments Division of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA

3 dispositifs médicaux avec un nom similaire

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Device Recall STRYKER NAVIGATION SYSTEM iNtellect Cranial Software
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
  • Description du dispositif
    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
Device Recall STRYKER NAVIGATION SYSTEM iNtellect Cranial Software Upgrade
  • Modèle / numéro de série
    verisions 1.0 and 1.1; all batches: HCU00F3002; J1800F3002; J1B00F3002; J1H00F3002; J1R00F3002; J2400F3002; J2K00F3002; J2U00F3002; J4E00F3002; and K4100F3003
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Verisions 1.0 and 1.1; all batches: HCE00F3002; J1A00F3002; and J2K00F3002
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
  • Description du dispositif
    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