Events

Rappel de ExacTrac

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
    67926
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1707-2014
  • Date de mise en oeuvre de l'événement
    2014-04-15
  • Date de publication de l'événement
    2014-06-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126619
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Cause
    When using a specific plan update workflow in combination with a non-brainlab treatment planning system (tps), there is a possibility in exactrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.
  • Action
    Brainlab sent a "FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" letter dated March 13, 2014 was sent to all affected customers. The letter identifies the affected product, problem, and actions to be taken. The letter includes specific instructions to users that are intended to reduce the likelihood of similar events occurring when using ExacTrac software version 5.5.5. The letter further states that Brainlab will be providing a software update to all customers. Brainlab will contact all customers to arrange for the software update within the following 6 months. Customers with any questions about this issue can contact Brainlab at 800-597-5911 or via e-mail at us.support@brainlab.com.

Device

ExacTrac
  • Modèle / numéro de série
    ExacTrac software version 5.5.5 is included in the following model / catalog numbers:   1) 20818B ET SOFTWARE 5.5.5;  2) 20820 ET SOFTWARE UPDATE 5.0 TO 5.5;  3) 49905D EXACTRAC COMPLETE SYSTEM UPG 3.X TO 5.5;  4) 49908C EXACTRAC SOFTWARE UPGRADE 3.X TO 5.5;  5) 49909A EXACTRAC SOFTWARE UPGRADE 4.X TO 5.5;  6) 49918 ET SOFTWARE UPDATE 5.5.X TO 5.5.5;  7) 49919 ET SOFTWARE UPDATE 5.0.X TO 5.5.5;  8) 49660A ET INFRARED SOFTWARE 5.5.5;  9) 49961 ET DATA PREP/REVIEW SYSTEM;  10) 49986 ET SYSTEM UPGRADE 3.X TO 5.5 NEW VAULT;  11) 49987 ET SYSTEM UPGRADE 4.X TO 5.5 NEW VAULT;  12) 49988 ET SYSTEM UPGRADE 4.X TO 5.5 SAME VAULT;  13) 49989 ET SYSTEM UPGRADE 5.0 TO 5.5 NEW VAULT;  14) 49990 ET SYSTEM UPGRADE 5.0 TO 5.5 SAME VAULT;  15) 49991 ET SYSTEM UPGRADE 5.5 TO 5.5 NEW VAULT
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of AZ, AR, CA, FL, KY, MA, NE, NY, TN, TX and the countries of Argentina, Australia, Brazil, Finland, India, Japan, Netherlands, Oman, Russia, and Taiwan
  • Description du dispositif
    ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG
  • Adresse du fabricant
    Brainlab AG, Kapellenstrasse 12, Feldkirchen Germany
  • Société-mère du fabricant (2017)
    Brainlab AG
  • Source
    USFDA