Events

Rappel de Device Recall Brainlab 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
    68741
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2146-2014
  • Date de mise en oeuvre de l'événement
    2014-06-24
  • Date de publication de l'événement
    2014-08-04
  • 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=128586
  • 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
    Brainlab ExacTrac - Product Code IYE
  • Cause
    When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions exactrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "ok" icon. if this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position.
  • Action
    Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated June 24, 2014, to all affected customers. The letter included instructions for customers to: 1) Avoid using plans with multiple isocenters in ExacTrac 6.0.4 whenever possible, and 2) If plans with multiple isocenters cannot be avoided and such a plan is used in ExacTrac v.6.0.4, then always select "Yes" in the dialog displayed to "keep the previous correction shift" when switching between isocenters and always verify all final treatment positions. Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact you to schedule the update within the next 6 months. Customers with questions can contact Brainlab at 800-597-5911 or via e-mail at us.support@brainlab.com.

Device

Device Recall Brainlab ExacTrac
  • Modèle / numéro de série
    ExacTrac Version 6.0.4; Model/Catalog Numbers: 1) 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE;  2) 20834C EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE;  3) 20835C EXACTRAC 6.0 IR MONITORING SOFTWARE;  4) 20853C EXACTRAC 6.0 X-RAY LIMITED SOFTWARE;  5) 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR);  6) 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR);  7) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR);  8) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED;  9) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC;  10) 49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4;  11) 49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4;  12) 49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R;  13) 49973B ET DATA PREP / REVIEW SYSTEM;  14) 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY;  15) 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED;  16) 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, CT, and IL; Internationally to France, Germany, Japan, Netherlands, Russia, and Slovenia.
  • Description du dispositif
    ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
  • Manufacturer
    Brainlab AG

Manufacturer

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