Events

Alerte De Sécurité sur Trade name: iPlan Surgical / Clinical Planning Software, brand Brainlab ///. Technical name: Surgical / Clinical Planning Software ///. ANVISA registration number: 80042070008 ///. Risk class: III - High Risk

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
    2017
  • Date
    2016-10-07
  • 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
    1) Immediately check the Leaf Shift Static value on all of your machine profiles on the iPlan RT Dose for MLC Elekta Agility: Ensure that this value is set to "0 mm". If another value is set, change this specific value to 0 (zero) to permanently resolve the potential problem described. 2) Return the Customer Response Form attached to the Product Notification to Brainlab.
  • Cause
    Potential effect of incorrect calculation of dose distribution when using treatment planning iplan rt dose with multiline collimator (mlc) elekta agility under specific circumstances. if the effect occurs for these specific treatment plans and is not detected by the user with the corresponding treatment-specific quality control, this may result in an unrecognized accumulated dose leak and not considered in small tissue regions, which may exceed the clinically acceptable limits and essentially causing undesirable long-lasting effects to the patient. no occurrences have been reported to brainlab by users regarding unwanted dose distributions administered to patients due to this problem.
  • Action
    Field Action Code CAPA-20160909-001728 triggered under the responsibility of the company Brainlab Ltda. Company is making correction in field of software update.

Device

Trade name: iPlan Surgical / Clinical Planning Software, brand Brainlab ///. Technical name: Surg...

Manufacturer

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