Events

Alerte De Sécurité sur IPlan Surgical / Clinical Planning Software, iPlan RT Dose. Anvisa Registration n ° 80042070008.

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 Brainlab Ltda.; Brainlab AG.

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
    1526
  • Date
    2015-03-11
  • 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
    According to the company's assessment, the severity of the situation is critical if incorrect and unintended positioning occurs for radiation and this is not detected by the user of the product. The possibility of occurrence is remote, as the potential problem occurs only under specific circumstances associated with workflows and specific patient placement scenarios. See Field Safety Notice for additional information. #### UPDATED ON 08/18/2019, the field actions documented by the company are archived in the area. If necessary, the area can reassess the action at any time.
  • Cause
    Potentially incorrect positioning of the patient in linac, when using treatment plans containing several ct scans.
  • Action
    If it is not clinically necessary, do not use multiple scans located within a treatment plan (to avoid, first, possibly incorrect designations of the Reference Set and Alignment Set). If you need to use multiple CT scans, for example, for recurring treatment planning for the same patient, ensure that the last CT scan is defined as both Alignment Set and Reference Set during treatment planning. See Field Security Notice for more information, available at AWARDING PUBLICATION.

Device

IPlan Surgical / Clinical Planning Software, iPlan RT Dose. Anvisa Registration n ° 80042070008.

Manufacturer

Brainlab Ltda.; Brainlab AG
  • Société-mère du fabricant (2017)
    Brainlab AG
  • Source
    ANVSANVISA