Events

Safety Alert for Trade name: /// (1). EQUIPMENT FOR ANGIOGRAPHY ARTIS (Record 10345162023) - Models: (i). Artis zee floor; (ii). Artis zee ceiling; (iii). Artis zeego; (iv). Artis Q biplane; (v). Artis zee biplane /// (2). AXIOM ARTIS FC AXIOM (Record 10234230075) - Model Artis FC /// (3). AXIOM ARTIS FA AXIOM (Record10234230093) - Model Artis FA /// (4). AXIOM ANGIOGRAPHY EQUIPMENT (Registration 10234230096) - Models: (i). Artis dFA; (ii). Artis dFC ### Technical Name: Angiography Equipment ### ANVISA Registration Number: (1). ARTIS EQUIPMENT FOR ANGIOGRAPHY (Record 10345162023) /// (2). AXIOM ARTIS FC AXIOM (Registration 10234230075) /// (3). AXIOM ARTIS FA AXIOM (Registro10234230093) /// (4). AXIOM ANGIOGRAPHY EQUIPMENT (Registration 10234230096) ### Risk Class: III (High Risk) ### Affected Series Numbers: APPENDIX

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.

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
    1972
  • Date
    2016-08-25
  • 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
    Recommendation to Users and Patients: Siemens recommends users to place an additional external filter in the water circuit, which will implement a protection mechanism to prevent functional failure of the pump system as a result of contamination. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    Possible cause of system defect due to contaminants in the form of biomass that can develop in the cooling system of the artis systems, resulting in damage to the pump system. the presence of contaminants in the tube cooling circuit impairs the performance of the pump. this failure may even lead to a functional failure of the system. the tube assembly may become superheated so that no radiation can be released.
  • Action
    Field Actions No. AX006 / 15 / S & AX007 / 15 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA deal with a correction in the field, correction of parts / pieces, by means of previous letter sending to the client.

Device

Trade name: /// (1). EQUIPMENT FOR ANGIOGRAPHY ARTIS (Record 10345162023) - Models: (i). Artis ze...

Manufacturer

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