Events

Alerte De Sécurité sur ExacTrac v. 6.0.x Patient Positioning System

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Brainlab AG.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-08-13
  • Date de publication de l'événement
    2015-08-13
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150813.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: brainlab exactrac v. 6.0.X patient positioning system medical device manufacturer, brainlab ag, has issued a medical device safety alert concerning its exactrac v. 6.0.X patient positioning system due to display of potentially incorrect digitally reconstructed radiograph (drr) for x-ray correction and verification [software version: exactrac v.6.0.0 through 6.0.5]. according to the manufacturer, an anomaly was detected in exactrac v.6.X when using exactrac version 6.0.0 through 6.0.5 for x-ray correction or verification of the patient position based on bony fusion. the phenomenon occurs under specific circumstances when using the exactrac x-ray module after a graphics memory error occurred at a previous patient positioning and the exactrac software has not been restarted since. the manufacturer advises users to take the following actions: 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 would be displayed, exit and re-start the exactrac software. to minimize the probability of this issue to occur for the affected exactrac versions: reduce the amount of contours exported to exactrac as far as possible (export only contours needed for positioning to exactrac). 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. generate drrs of that phantom plan once by selecting the define drr settings tab, before loading any other patient treatment plans the manufacturer will provide a software update to affected customers. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 13 august 2015.

Device

ExacTrac v. 6.0.x Patient Positioning System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Brainlab ExacTrac v. 6.0.x
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG