Events

Safety Alert for ARTIS EQUIPMENT FOR ANGIOGRAPHY, Registration 10234230190 - Serial Numbers: 121125

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
    1680
  • Date
    2015-08-26
  • 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 Ltda informs that in the described situation, the Artis system does not move alone, the movement continues being initiated by the operator. However, when this movement occurs, the system may unexpectedly have a higher than usual speed, potentially resulting in a collision. The company informs that the only equipment affected in Brazil is not yet installed.
  • Reason
    Siemens healthcare has identified a possible position sensor failure on the rotating base shaft that is not being detected by the system software. after activating operator movement, the c-arm system may move unexpectedly faster than normal.
  • Action
    The company informs that this problem will be solved with the software update through the modification AX037 / 15 / S (Patch 2). After installing this update, the possible speed of the Artis system will be limited to the allowed level. More information in the Customer Letter

Device

ARTIS EQUIPMENT FOR ANGIOGRAPHY, Registration 10234230190 - Serial Numbers: 121125

Manufacturer

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