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: 121125

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 Healthcare GmbH; Siemens Healthcare GmbH.

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
    2076
  • Date
    2017-01-06
  • 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
    The software problem can be corrected when you restart the system. It may take up to 8 minutes to restart the system. Normal emergency processes should be implemented in the event of a system failure. Ensure that these processes are prepared in advance until the update is applied. ### UPDATED ON 10/26/2017, the company submitted the completion report of the field action proving the sending of the security warning to the client with evidence from the science and all actions completed.
  • Reason
    The notification is intended to inform a corrective measure addressing two possible causes of a system defect and mutually independent. - in artis systems with a100plus or a100g generators, an attempt to resume operation after detecting a fault (such as a short-circuit in the x-ray tube, for example) may result in failure of a module in the high- voltage; - for bi-plane systems with the vd11b software version since april of this year, software problems in conjunction with graphics cards may, in rare cases, result in loss of presentation of images in the examination room.
  • Action
    Field Action Code AX001 / 16 / S & AX002 / 16 / S triggered under the responsibility of Siemens Healthcare Diagnósticos SA Company will make Field Correction.

Device

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

Manufacturer

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