Events

Alerte De Sécurité sur Commercial Name: Digital Mammography Device Technical Name: Mammography Device ANVISA Registration Number: 10345162027 Hazard Class: III Model Affected: MAMMOMAT Inspiration Serial Numbers Affected: 3063; 3395; 3400; 3630; 3639; 3828; 3833; 4169; 4266; 4274; 4275; 4276; 4451; 4527; 4704; 4708; 4710; 5047; 5078; 6044; 6204; 6356; 6488; 6873

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.

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
    2168
  • Date
    2017-02-10
  • 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
    To avoid the problem of inactivating the biopsy functionality, when the error message is displayed, the user is advised not to close the window but cancel the active target first and then close the error message window. After completing these steps, the user can start from the beginning. It is advisable not to use the inversion tool while the scout image is active. In the event of system crash, the Acquisition Workplace must be restarted. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • Cause
    The company has identified in mammomat inspiration systems with vb30 software version and with biopsy functionality that there is a potential for potential error that blocks the biopsy functionality, leaving it unavailable in situations where there is a compression force decrease or when there is use of the tool. inversion while the scout image is active during the targeting phase.
  • Action
    Field Action Code XP040 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will letter to the client.

Device

Commercial Name: Digital Mammography Device Technical Name: Mammography Device ANVISA Registratio...

Manufacturer

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