Events

Rappel de Device Recall STRYKER NAVIGATION SYSTEM iNtellect Cranial Software

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Stryker Instruments Division of Stryker Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    57487
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1404-2011
  • Date de mise en oeuvre de l'événement
    2010-11-10
  • Date de publication de l'événement
    2011-02-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96361
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Neurological Stereotaxic Instrument - Product Code HAW
  • Cause
    When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. this may lead to insufficient or inaccurate correlation results or incorrectly shown orientation of every second image series during navigation.
  • Action
    Urgent: Medical Device Recall Notification letters were sent on 12/3/2010, and software upgrades were to be performed in the field by the end of 2010. Specific Customer Instructions: 1) Locate the units listed in the notification. 2) Distribute this notification to all departments affected. 3) Return the enclosed business reply form to confirm receipt of this notification and identify how many affected units are currently in your inventory. 4) Once the new software is available, Stryker will dispatch a service tech in order to update the software. Note: Software upgrades for all applications will be available by the end of the year. The upgrades will be scheduled as we receive your business reply form. Note: If you currently have a Time License or Pay Per Use card, a new one will be issued to you at the time of the update. 5) If you have loaned or sold any of the units listed in this notification, please, forward a copy of this notice to the new users and advise Stryker of the new users name and their new location. 6) If you have disposed of any of the affected units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial numbers. Questions regarding this recall should be directed to Stryker Field Action Team at 800-800-4236, ext 3808, 3584, or 4354 between the hours of 8 a.m. - 5 p.m. Monday - Friday.

Device

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

Manufacturer

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