Events

Alerte De Sécurité sur Trade name: LINEAR PRIMUS ACCELERATOR Technical name: Linear Accelerator ANVISA registration number: 10234230073 Hazard class: III Serial numbers affected: 5529; 5746; 5828

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 Siemens Healthcare Diagnósticos S.A; Siemens AG; Siemens Medical Solutions USA, Inc..

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
    2225
  • Date
    2017-03-14
  • 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
    Despite security measures, there may be scenarios that are not covered by the software. Therefore, during automatic sequencing, the operator must pay attention to any movements of the gantry and the treatment table, and deviations or overlaps of the table applied in accordance with the treatment plan and carry out the preventive measures described in the letter of notification TH012 / 14 / S.
  • Cause
    Siemens healthcare diagnostics reports that previous afs motion protection software considered only the critical definitions of isocentric and eccentric table positions, but not a lateral deviation from the treatment table. in addition, the previous software required that the table setting be set to "automatic" in all parameters. if the operator had set the table's isocentric rotation to "manually" and the order of movements to "table first", the previous software ignored this setting. if a move from the gantry and the table to the next treatment field was required, the software did not stop the afs so as to allow manual table movement before the gantry moves, which would be automatically moved to the next target position.
  • Action
    Field Action Code TH005 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make correction in the field.

Device

Trade name: LINEAR PRIMUS ACCELERATOR Technical name: Linear Accelerator ANVISA registration numb...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens AG; Siemens Medical Solutions USA, Inc.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA