Events

Rappel de Brainlab AG ExacTrac 6.0.x

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
    71898
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2440-2015
  • Date de mise en oeuvre de l'événement
    2015-08-05
  • Date de publication de l'événement
    2015-08-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139302
  • 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
    Exactrac 6.0 patient positioning system: display of potentially incorrect digitally reconstructed radiograph (drr) for x-ray correction and verification.
  • Action
    Brainlab intends to distribute the Field Safety Notice / Product Notification letter CAPA-20150713-001446, dated July 20, 2015, to the customers. The letter provides instructions for the user on how to address this issue, and to avoid a patient and treatment target position potentially different than intended due to this issue. The Field Safety Notice / Product Notification letter states that as generally required, always verify that the correct DRRs for the current patient are displayed in ExacTrac and an accurate fusion to the X-Ray images is possible for patient positioning. In case incorrect DRRs are displayed, exit and re-start the ExacTrac software. To minimize the probability of this issue occurring for the affected ExacTrac versions: -Reduce the amount of contours exported to ExacTrac as far as possible. -Avoid exporting large contours, such as couch top models, to ExacTrac. -After every (re-)start of the ExacTrac application on any workstation, always first load a phantom plan not containing contours. The Field Safety Notice / Product Notification letter states that as a general reminder the user should always follow the instructions and warnings as described in the user guide. In the context of this notification please specifically consider the safety notes relevant for X-ray correction and verification: -The image overlay functions must be used to verify fusion accuracy in both image views, especially if the images contain a series of similar structures such as vertebrae. -Do not perform patient treatment unless accurate image fusion is possible. -Large correction shifts (e.g. greater than 10 mm) may indicate incorrect automatic fusion. In such cases, verify the correction shift a second time. Brainlab Corrective Action: 1. Existing potentially affected ExacTrac 6.0.x customers receive the product notification information. 2. Brainlab will provide a software revision (ExacTrac v. 6.0.6) with this issue solved to affe

Device

Brainlab AG ExacTrac 6.0.x
  • Modèle / numéro de série
    Affected are ExacTrac versions 6.0.0 through 6.0.5 (v. 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5).   Serial numbers/lot numbers are not applicable for a software version. Software revisions of the ExacTrac software have a specific software version number.   Model/catalogue numbers: 70359-01 EXACTRAC 6.0 IR POSITIONING SOFTWARE FOC 20833 EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833A EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833D EXACTRAC 6.0 IR POSITIONING SOFTWARE 49926 ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49926A ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49927 ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49927A ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49933 ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49933A ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49934 EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49996 ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49996A ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49997 ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED 49997A ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED 49928 ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49928A ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R; 49939A ET SOFTWARE UPDATE 6.0.X to 6.0.5 P&R; 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4 49936B ET SOFTWARE UPDATE 6.0.X TO 6.0.5 49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4 49938A ET SOFTWARE UPDATE 6.0.3TO 6.0.5 49973 ET DATA PREP / REVIEW SYSTEM 49973A ET DATA PREP / REVIEW SYSTEM 49973B ET DATA PREP / REVIEW SYSTEM 49998 ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49998A ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 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 the states of AL, AZ, AK, CA CO, CT, FL, GA, ID, IL IN, KY, LA, MD, MA, MI, MN, NE, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, and WI; and, the countries of Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Netherlands, Panama, Qatar, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
  • Description du dispositif
    ExacTrac 6.0.x || Patient Positioning System, Radiation therapy. || 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.
  • Manufacturer
    Brainlab AG

Manufacturer

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