Events

Safety Alert for EQUIPMENT FOR ANGIOGRAPHY AXIOM ARTIS. ANVISA Registry: 10234230096 (Model FA). Affected Models: FA, FC, dFC, dTC, dFA and dTA.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens 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
    961
  • Date
    2009-03-19
  • 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
    Siemens Ltda informed the ANVISA's Technovigilance Unit (UTVIG / ANVISA) that has already sent a communication letter to its customers, reporting the problem and advising on the necessary actions. The company also reported that it intends to update all AXIOM ARTIS systems that cause the problem reported in this alert, but has not yet reported the start date of the field action to be performed. #### Update on 04/20/2012: Accordingly with communication sent on 04/17/2012 by the company to UTVIG / ANVISA (file no. 0324770128, 04/19/12), the field action has already been finalized - software correction. The company reported that it performed the correction on ten equipments installed in Brazil.
  • Reason
    When a specific sequence of actions is performed, the generated images may be corrupted or contain non-clinical measures. the problem is related to the use of qva, qca or lva quantification software in combination with certain versions of axiom artis software.
  • Action
    Recommended actions for product users are as follows: When using the "Catheter Calibration" method as the basis for QVA, QCA or LVA quantification, the operator must not change the selected image after selecting the calibration method; that is, the calibration image should be selected before "Catheter Calibration" is started. Once "Calibration by Catheter" is selected, the image can no longer be changed. If your health care facility has affected equipment, contact the product registration holder to inform them and ask for the necessary steps to correct the equipment.

Device

EQUIPMENT FOR ANGIOGRAPHY AXIOM ARTIS. ANVISA Registry: 10234230096 (Model FA). Affected Models: ...

Manufacturer

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