Events

Safety Alert for ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 80015490090 Hazard Class: III Affected Model: Artis Zee Ceiling, Artis Zee Floor, Artis Zee biplane, Artis Zeego, Artis Q biplane

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
    2209
  • Date
    2017-03-06
  • 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
    Users should notify and instruct their teams to be aware of this problem and if there are any questions regarding the addendum to the operating instructions, the company should be contacted.
  • Reason
    Siemens healthcare diagnostics informs that in the indicated artis systems a semi-automatic focus switch is implemented. interacting with a special type of defect due to wear on the "small" and "micro" (if present) focus, an automatic focus is performed when the pedal is pressed several times. this special system function is not fully written in the currently available operating instructions. if a focus (small / micro) develops a fault, an alternative focus can be selected by pressing the pedal repeatedly. this allows the radiation to be generated again so that clinical treatment or diagnosis can proceed.
  • Action
    Field Action Code AX058 / 16 / S triggered under the responsibility of Siemens Healthcare Diagnósticos SA Company will update, correct or supplement the instructions for use.

Device

ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 800...

Manufacturer

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