Events

Rappel de Device Recall BrainLAB Target Positioner for Leksell Headring

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 Brainlab AG.

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
    38170
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1010-2007
  • Date de mise en oeuvre de l'événement
    2007-06-05
  • Date de publication de l'événement
    2007-07-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-02-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53091
  • 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
    Radiation therapy treatment Target Positioner - Product Code IWY
  • Cause
    Target alignment error : a mechanical component/software incompatibility caused by a specific combination of the brainlab target positioner version 40700-3a for leksell headrings and brainlab planning software resulted in a 1.25 mm shift in target area alignment during radiosurgery treatment.
  • Action
    BrainLAB immediately notified all customers with the BrainSCAN or iPlan RT Dose software in combination with the BrainLAB Target Positioner for Leksell Headring, via e-mail on June 5, 2007. The Urgent Medical Device Product Notification letter dated June 4, 2007 included in the e-mail informed the customers that both the BrainSCAN and iPlan RT Dose treatment planning software calculates the isocenter position printed on the Target Positioner Overlays shifted 1.25 mm in cranial direction from the intended position, when the BrainLAB Target Positioner for Leksell Headring Revision A is used. The customers were instructed to cease using the BrainSCAN or iPlan RT Dose software in combination with the BrainLAB Target Positioner for Leksell Headring for treatment planning and patient set-up. An updated target positioner will be provided to the customers to correct the problem, estimated to be available in September 2007. Any questions were directed to their local BrainLAB Customer Support Representative or CAPA Manager Markus Hofman at 49-89-99-15-68-44 or 1-800-597-5911 in the U.S.

Device

Device Recall BrainLAB Target Positioner for Leksell Headring
  • Modèle / numéro de série
    Catalog/version number 40700-3A, all serial numbers
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Ohio, Washington and France
  • Description du dispositif
    BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions 3.0, 3.0.1 and 3.0.2) and BrainSCAN (version 5.31) Radiotherapy Treatment Planning Software, ; BrainLab AG, Ammerthalstrasse 8, 85551 Heimstetten, Germany; catalog/version number 40700-3A
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Adresse du fabricant
    Brainlab AG, Ammerthalstrasse 8, Kirchheim B. Muenchen Germany
  • Source
    USFDA