Events

Alerte De Sécurité sur COMPASS 3.1 / 3.1a

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

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
    2015-02-16
  • 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_20150216.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: iba dosimetry compass 3.1 / 3.1a medical device manufacturer, iba dosimetry, has issued a field safety notice concerning compass 3.1 / 3.1a [catalogue number: cs10-100. manufacturing date: may 2014 (for version 3.1) and nov 2014 (for version 3.1a)]. the manufacturer found that dose reconstruction for dmlc plans from monaco or eclipse-11 when the jaws move or mlc leaves reverse during beam on was not scaled correctly. normally, during the measurement-based correction process employed by compass, a step called “delivery error scaling” is carried out in order to correct for an overall absolute dose difference level between measured and predicted responses. a scale factor derived from this difference in absolute output is averaged over all detector pixels. the error occurs as the “delivery error scaling” is not properly applied. the reconstructed dose becomes erroneous although the predicted response remains correct. the error occurs when compass is used to acquire measurement data and the evaluation is performed using reconstructed dose. if the predicted response is not evaluated together, the erroneously reconstructed dose may not be noticed. this could happen if the measurement shape is correct but the absolute level is wrong. the manufacturer will provide software update to correct this issue. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. 16 february 2015.

Device

COMPASS 3.1 / 3.1a
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: IBA Dosimetry COMPASS 3.1 / 3.1a
  • Manufacturer
    IBA Dosimetry

Manufacturer

IBA Dosimetry