Events

Alerte De Sécurité sur Digital Mammography Unit, MAMMOMAT Inspiration - Model: MAMMOMAT Inspiration - Record: 10234230164 - Risk Class III - High Risk - Technical Name: Mammography Unit - Series: 3064; 5047

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 Ltda.; 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
    1462
  • Date
    2014-10-20
  • 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
    The company recommends "(...) inspect the safety switch before each biopsy until the problem is solved and then carefully follow the instructions in the user manual - safety switch chapter. The customer will be advised to wait for the Service Team to schedule field corrections and to file the letter with the Operator's Manual. In addition, Siemens advises to inform all personnel of the organization who need to be aware of this problem and act accordingly. Send this safety information to any other institutions that may be affected by this measure. "
  • Cause
    Problem: according to the company: "stereotactic biopsy devices for mammomat inspiration mammography systems may have integrated a safety switch that causes a functionality failure. the pin included in the safety switch may not exert sufficient pressure on the safety circuit to prevent movement. the needle positioner can move even with the safety switch on the side. if this occurs with the needle already inserted, it can lead to an unintentional injury to the patient. ".
  • Action
    Company will perform Correction in the field. Code: XP053 / 14 / S

Device

Digital Mammography Unit, MAMMOMAT Inspiration - Model: MAMMOMAT Inspiration - Record: 1023423016...

Manufacturer

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