Events

Alerte De Sécurité sur OBI 1.3, OBI 1.4; OBI 1.5; TrueBeam 1.0; Offline Review 1.0 - 2.0

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

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
    2011-11-17
  • 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_20111117b.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
    Field safety notice: varian obi 1.3, obi 1.4; obi 1.5; truebeam 1.0; offline review 1.0 - 2.0 medical device manufacturer, varian, has issued an urgent medical device correction concerning obi 1.3, obi 1.4; obi 1.5; truebeam 1.0; offline review 1.0 - 2.0. an anomaly has been identified in the 3d match environment of obi 1.3, obi 1.4, obi 1.5, truebeam 1.0 and offline review 1.0 – 2.0 when using reference ct datasets which contain a critical number of slices. when these reference ct datasets are used to create a reference ct volume in the 3d match environment, in a small number of cases, the scaling of the ct volume will be incorrect and the ct volume will appear larger – in the slice direction - than it actually should be. if this improperly scaled ct volume is used for 3d matching, the cbct volume and patient may be positioned too far superiorly. according to the local supplier, the affected device has been distributed in hong kong. varian has notified all possibly affected customers and developing a correction for this issue. if you are in possession of the affected products, please contact supplier for necessary actions.

Device

OBI 1.3, OBI 1.4; OBI 1.5; TrueBeam 1.0; Offline Review 1.0 - 2.0
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Varian OBI 1.3, OBI 1.4; OBI 1.5; TrueBeam 1.0; Offline Review 1.0 - 2.0
  • Manufacturer
    Varian

Manufacturer

Varian