Events

Safety Alert for AXIOM ARTIS, Artis dFA and Artis dFC models, registration 10234230096; serial numbers affected: 35117; 35318; 35396; 35485; 35622; 35729; 35748; 35751; 35817; 35862; 35872; 35883; 35884; 35885; 35910; 35913; 35936; 35949; 50138. Risk class III

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
    1708
  • Date
    2015-10-02
  • 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 registry holder informs that the system will not move by itself and must be started by the operator. When moving, the system may unexpectedly exceed its normal speed, with possibility of collision. In addition to correcting the failure, the software update will provide fixes for the operating system as well as a new version of anti-virus protection.
  • Reason
    The company has identified position sensor failure on the oscillating base axis that is not detected by the system software. after activation of the movement by the operator, the arm system c can move unexpectedly faster than normal.
  • Action
    Updating the VB35D software version to fix the problem. The customer may continue to use the equipment while awaiting the appointment of the engineer.

Device

AXIOM ARTIS, Artis dFA and Artis dFC models, registration 10234230096; serial numbers affected: 3...

Manufacturer

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