Events

Safety Alert for ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 10345162023 Hazard Class: III Model Affected: Artis Q biplane, Artis Q ceiling, Artis Q floor, Artis Q.zen biplane, Artis Q.zen ceiling , Artis Q.zen floor, Artis zeego Serial numbers affected: 161013, 1211250

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
    2079
  • 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 systems with Gigalix X-ray tube of 2 focuses, to acquire the acquisition of images with the great focus after the manual selection of a corresponding organ program. Fluoroscopy is possible in systems with a 3-spot Gigalix X-ray tube with a "small" or "micro" focus that is still intact through the manual selection of a corresponding fluoroscopy program. a large focus is possible.There are standard emergency procedures in place in case of system failures.It is recommended to reinforce these procedures until the update has been done.
  • Reason
    For artis systems with the software version vd11 and the gigalix x-ray tubes, the semi-automatic focus switch may, in cases of defects in the "small" and "micro" foci (if present), not operate as intended by pressing the pedal repeatedly. 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.
  • Action
    Field Action Code AX048 / 16 / S & AX049 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make Correction in the field.

Device

ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 103...

Manufacturer

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