Events

Safety Alert for Product Name: ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 10345162023 Hazard Class: III Affected Model: Artis zeego, Artis zee biplane, Artis zee ceiling, Artis zee floor, Artis zee Multi-purpose Serial Numbers affected: 147551; 147708; 136918; 136933; 136947; 137020; 137026; 137042; 137045; 137074; 137105; 137164; 137379; 137411; 137658; 160457;

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
    2081
  • 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 for Megalix X-ray tube systems to perform focussed acquisition of images 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. Consider reinforcing these procedures until the upgrade has been made.
  • Reason
    For artis systems with software versions vc21c and vd11 and megalix cat + x-ray tubes, the semi-automatic focus switch may, in cases of defects in the "small" and "micro" foci (if present), not work as intended when pressing the pedal. this type of focus defect, which causes the failure of the semiautomatic focus switch, becomes more likely as the life of the x-ray tube increases. as a matter of clarity, systems with the vc21b software version do not are affected.
  • Action
    Field Action Code AX050 / 16 / S & AX051 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make Correction in the field.

Device

Product Name: ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registrati...

Manufacturer

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