Events

Safety Alert for Equipment for angiography Artis. Model: Artis Zeego. Anvisa Registry n ° 10234230158.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos Ltda..

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
    1452
  • Date
    2014-10-24
  • 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 overseas manufacturer performed the problem analysis, evaluating all the inherent risks, which generated corrective action in the field. Based on the investigation and mitigation of the risk conducted, this action was classified as a medium risk to health, its severity being critical and its probability of occurrence extremely unlikely. According to the company, this is a possible hardware failure that has no influence on the treatment of patients. The customer will be advised to wait for the Service Team to schedule field corrections and to file the letter with the Operator's Manual. In addition, Siemens advises to inform all personnel of the organization who need to be aware of this problem and act accordingly. According to the company the field action was finalized
  • Reason
    A cable inside the c-arm of affected systems may have been improperly positioned. without an additional measure, there is the possibility of a cable inside the c-arm. the problem will not occur systematically but sporadically over the lifetime of the system.
  • Action
    Correction in the field / Correction of parts or parts.

Device

Equipment for angiography Artis. Model: Artis Zeego. Anvisa Registry n ° 10234230158.

Manufacturer

Siemens Healthcare Diagnósticos Ltda.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA