Events

Alerte De Sécurité sur ONCOR IMPRESSION LINEAR ACCELERATOR. Anvisa Registry: 10234230126.

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
    958
  • 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
    According to a communication letter sent to UTVIG / ANVISA by Siemens Ltda, the company will send a communication letter to its customers. The company also reported that equipment under risk in the country has not yet been installed, that is, they are not yet in operation. #### Update on 04/20/2012: According to communication sent on 04/17/2012, 2012 by the company for UTVIG / ANVISA (file no. 0324770128 of 04/19/12), the company has already closed the field action. The three equipments affected by the problem in Brazil were corrected by the company through a software update.
  • Cause
    The display of the equipment may be misaligned by about 4mm when compared to the reference image. with this, a single exposure image can be overwritten by a dual exposure image.
  • Action
    The company that owns the product registration, Siemens Ltda, has not yet begun to communicate with users affected by this alert. According to the company, to avoid the possibility of overwritten images from a single exposure by a dual exposure image, users should acquire / load images of the same type of exposure during a session. If this recommendation is difficult to implement at the health facility, users are advised to select SAVE (save) to each image immediately after a modification. The ANVISA Technovigilance Unit (UTVIG / ANVISA) is monitoring this case.

Device

ONCOR IMPRESSION LINEAR ACCELERATOR. Anvisa Registry: 10234230126.

Manufacturer

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