Events

Alerte De Sécurité sur COHERENCE ONCOLOGIST software (integral part of LINEAR PRIMUS ACCELERATOR). ANVISA registration: 10234230073.

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 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
    959
  • Date
    2009-03-12
  • 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
    Siemens Ltda reported that it has already begun sending a letter of communication to customers affected by the problem. The updated software version, containing the correction of the problem, is already being elaborated by the company. #### Update on 04/20/2012: According to communication sent on 04/17/2012 by the company to UTVIG / ANVISA (file no. 0324770128, of 04/19/12), the field action has already been completed - software fix and addendum to the product operation manual.
  • Cause
    The display of an image window acquired with a flat panel optivue (with software version - coherence oncologist - 2.0 or higher) may be offset relative to the reference image.
  • Action
    Siemens Ltda, the company that owns the product registration in Brazil, informed the UTVIG / ANVISA that it has already begun sending letters of clarification to the customers affected by the problem. If they have not yet received the company's letter of clarification, users who own the equipment should contact the company (see the Manufacturer Description field in this alert). Users who have already received the letter of clarification should attach it in the Coherence Oncologist manual until the software update is run by Siemens.

Device

COHERENCE ONCOLOGIST software (integral part of LINEAR PRIMUS ACCELERATOR). ANVISA registration: ...

Manufacturer

Siemens Ltda.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA