Events

Safety Alert for Trade Name: ANGIOGRAPHY EQUIPMENT; Model: AXIOM Artis dFA, AXIOM Artis dFC, registration 10234230096, Class III //// Trade Name: ARTIS ANGIOGRAPHY EQUIPMENT; registry: 10345162023; class III

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A.; Siemens AG..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1857
  • Date
    2016-03-18
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Siemens Healthcare advises users of the target devices of this field action to wait until the Siemens engineering team schedules a field visit so that the problem is finally corrected.
  • Reason
    Siemens healthcare informs about the possibility of leakage in the detector's refrigeration system, which may cause fluids to flow into the equipment's structure. failure of the system and even locking can occur due to the loss of the cooling system. however, siemens healthcare notes that this possible hardware failure does not influence the treatment of patients.
  • Action
    Notification made by Siemens Healthcare Diagnósticos SA in compliance with Resolution RDC 23/2012.

Device

Trade Name: ANGIOGRAPHY EQUIPMENT; Model: AXIOM Artis dFA, AXIOM Artis dFC, registration 10234230...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens AG.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA