Events

Safety Alert for Artistic Angiography Equipment, Model: Artis Zee Biplane and Artis zee floor, register: 10234230190, hazard class III, serial numbers :. Artis Zee Biplane: 154646; Artis zee floor: 136215; 136926; 136933; 136936; 136944; 136947; 136977; 136995; 137020; 137033; 137042; 137045; 137074; 137083; 137088; 137089; 137090; 137094; 137098; 137099; 137100; 137102; 137143; 137158; 137159; 137160; 137161; 137162; 137164; 137182; 137191; 137246; 137281; 137299; 137300; 137306; 137310; 137324; 137346; 137379; 137382; 137387; 137411; 137416; 137426; 137436; 137447.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Ltda.; 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
    1638
  • Date
    2015-07-13
  • 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
    According to the manufacturer, the Artis system may not move on its own initiative and the movement initiated by the operator. However, when moving, the speed of the system may be higher than usual and cause collision.
  • Reason
    Position sensor failure in the hinged base shaft that is not detected by the system software. the c-arm system can move, unexpectedly, faster than normal.
  • Action
    The company that owns the registry will update the software. The recommendation, as long as field correction is not performed, is for customers to continue to use the system.

Device

Artistic Angiography Equipment, Model: Artis Zee Biplane and Artis zee floor, register: 102342301...

Manufacturer

Siemens Ltda.; SIEMENS AG.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA