Events

Safety Alert for Equipment for angiography Artis, models Artis zee ceiling; Artis zee floor; Artis zeego, registration 10234230190, hazard class III, lots / series: 135297; 135329; 135785; 135816; 135825; 135835; 135848; 135869; 135941; 135969; 135980; 135984; 135991; 136056; 136060; 136068; 136115; 136119; 136136; 136144; 136199; 136213; 136214; 136276; 136282; 136283; 136284; 136285; 136288; 136301; 136320; 136355; 136363; 136369; 136373; 136419; 136421; 136424; 136425; 136440; 136443; 136457; 136492; 136580; 146646; 160143; 160343; 160360; 160467.

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
    1652
  • Date
    2015-07-24
  • 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
    Considering the problem related to the locking of the system in the "Fluoro Bypass" mode, it is possible that there is no radiation release and no fluoroscopic images are acquired. The risk would be more related to the delay due to the system restart. In the second problem presented the risk are related to the possible unexpected movement of the equipment resulting in collision.
  • Reason
    Two problems with the system have been described by the company that holds the registry: the first would be in case of an error in the equipment and it is in the "bypass fluoro" mode, while the x-ray blocking function is active, it will not be the only way out of this function is to solve the root cause of the equipment being in the "bypass fluoro" mode or to restart the system. the other problem is related to the possible failure of the position sensor on the articulated base axis that is not detected by the system software. following activation of operator movement, the c-arm system may move unexpectedly faster than normal.
  • Action
    The company intends to continue to use the equipment until the company engineer's visit is made for field correction of the equipment. The field correction corresponds to the software update by installing two packages (11 and 12).

Device

Equipment for angiography Artis, models Artis zee ceiling; Artis zee floor; Artis zeego, registra...

Manufacturer

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