Events

Safety Alert for Angiography equipment, risk class III: AXIOM ARTIS FC, registration 10234230075, lots / series: 10151, 10279, 10312, 10320, 10379, 10409, 10481, 10501, 10513, 10520, 10526, 10533./// AXIOM ARTIS FA , registration: 10234230093, lots / series: 25062; 25179; 25282; 25329; 25330; 25379; 25418; 25447; 25452. /// Angiography equipment models: AXIOM ARTIS dFA; AXIOM ARTIS dFC, registration 10234230096, batches / series: 35117; 35318; 35396; 35485; 35622; 35729; 35748; 35751; 35817; 35862; 35872; 35883; 35884; 35885; 35910; 35913; 35936; 35949; 50138./// Angiography equipment Artis models ARTIS ZEE CEILING, ARTIS ZEE FLOOR AND ARTIS ZEEGO, registry 1023420190, lots / series: 135297; 135329; 135758; 135785; 135816; 135825; 135835; 135848; 135869; 135941; 135969; 135980; 135984; 135991; 136056; 136060; 136067; 136068; 136098; 136115; 136119; 136136; 136144; 136199; 136213; 136214; 136215; 136276; 136282; 136283; 136284; 136285; 136288; 136301; 136320; 136355; 136363; 136369; 136373; 136419; 136421; 136424; 136425; 136440; 136443; 136457; 136492; 136580; 136908; 136918; 136926; 136933; 136936; 136944; 136947; 136977; 136995; 137020; 137026; 137033; 137042; 137045; 137074; 137083; 137088; 137089; 137094; 137098; 137099; 137100; 137102; 137105; 137120; 137143; 137158; 137159; 137160; 137161; 137162; 137164; 137182; 137246; 146646; 147531; 147551; 147582; 147600; 147602; 147617; 147619; 147637; 147650; 147706; 147708; 147744; 160143; 160343; 160360; 160415; 160457; 160467; 160836.

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
    1653
  • 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
    The holder informs that the problem involves a failure of the equipment having no influence on the treatment of patients.
  • Reason
    In case the table is near its maximum extension at the end of the head and there is a large amount of liquid on the table surface, the liquid may infiltrate the table through the existing fault and cause contamination of the electronic components. in the event of contamination, table movements may not occur.
  • Action
    The holding company will do the sealing in the failure of the top cover of the table column. This will ensure protection against ingress of liquids. The company will contact customers to schedule a visit to carry out corrective action.

Device

Angiography equipment, risk class III: AXIOM ARTIS FC, registration 10234230075, lots / series: 1...

Manufacturer

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