Events

Alerte De Sécurité sur COMPASS Software version 3.1

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 GmbH.

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
    2014-10-23
  • Date de publication de l'événement
    2014-10-23
  • 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_20141023b.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 gmbh compass software version 3.1 medical device manufacturer, iba dosimetry gmbh, has issued a medical device safety alert concerning its compass software version 3.1 [catalogue number: cs10-100]. based on a customer complaint the manufacturer identified that compass 3.1 has an error in the reconstruction of the dose distribution for specific plans: monaco-dmlc and eclipse imrt plans with jaw tracking- option enabled. the reconstruction results in the same dose distribution as the dose computation, which has the potential of being erroneous. based on this information the manufacturer performed a health hazard analysis for compass 3.1and determined that this failure may have an impact on the intended use of compass. the evaluation of the risk for the patient resulted in a region where a risk reduction is necessary. therefore, the affected customers have to be informed about the malfunction in the software. additionally the medical device compass 3.1 has to be corrected. affected users are advised not to apply patient plan verification for monaco-dmlc and eclipse imrt plans with jaw tracking option enabled using the 3d dose reconstruction (measurement-based) calculation method with compass 3.1 until the corrected version is available and installed. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 23 october 2014.

Device

COMPASS Software version 3.1
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: [23 Oct 2014] IBA Dosimetry GmbH COMPASS Software version 3.1
  • Manufacturer
    IBA Dosimetry GmbH

Manufacturer

IBA Dosimetry GmbH