Events

Safety Alert for Technical Name: Equipment For Angiography ANVISA Registration Number: 10234120096 Hazard Class: III Affected Model: AXIOM Artis dFA, AXIOM Artis dFC Serial numbers affected: 35117; 35318; 35396; 35485; 35622; 35729; 35748; 35751; 35817; 35862; 35872; 35883; 35884; 35885; 35910; 5913; 35936; 35949; 50138

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A.; 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
    2080
  • Date
    2016-12-06
  • 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
    It is possible, in 2-spot Megalix X-ray tube systems, to acquire images with large focus after manual selection of a corresponding organ program. In 3-spot Megalix X-ray systems, fluoroscopy is possible with the "small" or "micro" focus that is still intact through the manual selection of a corresponding fluoroscopy program. In addition, the acquisition of images with the big focus is possible. Standard emergency procedures must be in place in case of system failures. Siemens recommends enforcing these procedures until the upgrade has been made.
  • Reason
    For axiom artis systems with the vb35e software version and megalix x-ray tubes, the semi-automatic focus switch may, in the case of a special type of defect in the "small" and "micro" foci (if present), not work desired when pressing the pedal. the focus defect, which causes the semi-automatic focus switch to fail, becomes more likely as the life of the x-ray tube increases.
  • Action
    Field Action Code AX052 / 16 / S & AX053 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make Correction in the field.

Device

Technical Name: Equipment For Angiography ANVISA Registration Number: 10234120096 Hazard Class: I...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens AG.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA