Events

Alerte De Sécurité sur Commercial name: Ultrasound Diagnostic System ACUSON //. Technical Name: Ultrasound Apparatus //. ANVISA Registration No. 10345162017 //. Risk class: II (Medium Risk) //. Serial numbers: 203148; 205101; 205242; 206678; 206819; 206857; 207039; 207574; 207636; 207842; 207923; 207988; 208130; 208132; 208135; 208179; 208332; 208548; 208676; 208678; 208837; 208873; 208904; 208942; 209048; 209088; 209120.

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 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
    1965
  • Date
    2016-08-03
  • 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
    Recommendation to users and patients: - do not use 6C1 HD and 18L6 HD transducers with CIVCO biopsy connectors for guided biopsy procedures. - do not reposition the region of interest of the Virtual Touch IQ from the original location (default). SEE TECNOVIGILANCE ALERTS: 1649; 1673 If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AEs) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Cause
    Siemens healthcare diagnósticos sa informs that the field action us006 / 16 / s consists of the software update. when using the equipment with the outdated software it is possible that: - when using the civco biopsy connectors in combination with the acuson s family screen orientations. the path of the biopsy needle may not match the orientation of the screen. this occurs on 6c1 hd and 18l6 hd transducers (alert 1673). - when repositioning the region of interest of the virtual touch iq from its original location (default), the lateral position of the measuring tool (indicated in yellow) may not be in line with the lateral position of the shear rate data (alert 1649).
  • Action
    Field Action No. US006 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA The Field Action deals with field correction, software update, upon previous sending of letter to the client. Recommendation to users and patients: - do not use 6C1 HD and 18L6 HD transducers with CIVCO biopsy connectors for guided biopsy procedures. - do not reposition the region of interest of the Virtual Touch IQ from the original location (default).

Device

Commercial name: Ultrasound Diagnostic System ACUSON //. Technical Name: Ultrasound Apparatus //....

Manufacturer

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