Events

Alerte De Sécurité sur SISTEMA ADVANTAGESIM MD - Registered at ANVISA under number 80071260089 - versions affected: 7.4 to 7.6 (inclusive).

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 GE Healthcare do Brasil Com. e Serviços para Equipamentos Médico-Hospitalares Ltda..

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
    975
  • Date
    2009-08-05
  • 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
    The AdvantageSim MD program supports loading multiple images from one scan at a time, and the problem cited may lead to incorrect image labeling. According to the holder of the product registration in Brazil, if incorrectly labeled images are used in RTSS (Radio Therapy Structure Set) system, they are most likely to be rejected by the treatment planning system by radiation. If the RTSS system does not do this rejection, such non-phased data used for treatment planning may be confused with each other, causing errors in radiation treatment planning. The registry holder has announced that it has already initiated field action (IMF 80125 - Field Modification Instruction) for the installation of a new version of AdvantageSim MD 7.7 software, in order to correct the problem. The Technovigilance Unit is following up on this case.
  • Cause
    Whenever several non-phased series are simultaneously loaded, there is the possibility of being incorrectly labeled, resulting in incorrect data being presented in the displayed image.
  • Action
    Recommended actions are as follows: (1) As a precautionary measure, the user must upload the non-phased series, one by one, in AdvantageSim MD; (2) Contact GE Healthcare do Brasil Ltda if it has not yet reported the problem.

Device

SISTEMA ADVANTAGESIM MD - Registered at ANVISA under number 80071260089 - versions affected: 7.4 ...

Manufacturer

GE Healthcare do Brasil Com. e Serviços para Equipamentos Médico-Hospitalares Ltda.