Events

Alerte De Sécurité sur On Board Imager / VARIAN RADIOTHERAPY SYSTEM with CBCT, Versions 1.4, 1.5 and 1.6 with CBCT 2.1.05 SP1-SP6, registration 10405410011, risk class III, lots / series H074200; H073676; H074373; H074390; H070897; H071472; H071657; H070418; H074494; H073721; H073249; H072087; H071455; H074151; H074298.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Varian Medical Systems Brasil Ltda.; Varian Medical Systems INC.

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
  • ID de l'événement
    1830
  • Date
    2016-02-29
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    Reinforced the need to adopt the following instructions: OBI version 1.5 and OBI 1.6: Navigate to the OBI application and select the "Cancel" button. The cancellation process can take anywhere from 5 to 30 seconds to complete. Restart the CBCT * acquisition process (See document CP-22609 in its entirety). OBI Version 1.4: Disable the CBCT field on the 4DITC workstation. Restart the OBI computer (s) and Reconstructor. Restart the OBI application. Enable the CBCT field on the 4DITC workstation. All versions of OBI: Contact your local Varian Medical Systems service department to report an incident of CBCT acquisition failure. #### UPDATED ON 08/24/2017, the company sent a completed action report of the field proving that a correction has been made as expected.
  • Cause
    Varian has received numerous reports on the locking of the acquisition of the on-board imager® cone beam ct [cbct] that prevents the reconstruction of the image. a repeat of the scan is required. there are two possible symptoms: 1) the cbct application stops updating the display during acquisition. 2) an exception occurs during acquisition. although the cbct projections have been acquired, it will not be possible to generate the reconstructed cbct and the scan must be repeated. varian company describes that no administration failures or injuries were reported due to this problem.
  • Action
    Action code CP-22609. Send security warning to all affected clients.

Device

On Board Imager / VARIAN RADIOTHERAPY SYSTEM with CBCT, Versions 1.4, 1.5 and 1.6 with CBCT 2.1.0...

Manufacturer

Varian Medical Systems Brasil Ltda.; Varian Medical Systems INC