Events

Alerte De Sécurité sur ExacTrac v. 6.x – Cone Beam Computed Tomography (CBCT) Import & Alignment Software

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
    2015-04-23
  • Date de publication de l'événement
    2015-04-23
  • 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_20150423.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.X – cone beam computed tomography (cbct) import & alignment software medical device manufacturer, brainlab ag, has issued a medical device safety alert concerning its exactrac v. 6.X – cone beam computed tomography (cbct) import & alignment software [software version: exactrac v. 6.X (v. 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0), in combination with varian c-series linac only]. according to the manufacturer, an anomaly was detected in exactrac v.6.X during phantom based acceptance testing. the phenomenon occurs under specific circumstances when using the exactrac cbct module with varian cbct images acquired with a varian c-series linear accelerator (linac) at a couch angle other than 0.0°. the manufacturer advises users to take the following actions: with immediate effect, always make sure the couch is at exactly 0.0° (displayed on the varian monitor) when acquiring a cbct set to import into the exactrac software. for varian systems providing an option to prevent a cbct acquisition for couch angles other than 0.0°, the manufacturer recommends selecting that option for use in combination with exactrac. continue to verify any exactrac cbct based correction using the exactrac x-ray verification and/or an external igrt procedure as mandatory. the manufacturer will provide a software update to affected customers. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 april 2015.

Device

ExacTrac v. 6.x – Cone Beam Computed Tomography (CBCT) Import & Alignment Software
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Brainlab ExacTrac v. 6.x – Cone Beam Computed Tomography (CBCT) Import & Alignment Software
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG