Events

Safety Alert for ULTRASOUND DIAGNOSTIC SYSTEM ACUSON SC2000, Registration 10234230166 - Serial Numbers: 400723; 400758; 401532.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Ltda.; Siemens AG; Siemens Medical Solutions USA, Inc..

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
    1679
  • Date
    2015-08-26
  • 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 reports the potential risk is that the Echocardiogram under Effort study must be performed again. It further informs that the problem will be solved by launching new software for customers who have not yet received the original software update.
  • Reason
    Siemens healthcare has identified that when conducting a 2d stress echocardiography study, there is a possibility of data loss in the acuson sc2000 system, in which selected videos can not be saved as part of the study.
  • Action
    The company advises that, in order to avoid possible risk, the following steps should be followed: - Select "Stress echocardiography"; - If applicable, reclassify videos from all stages and views; - Do not return to "Stress Echo Screening" to select reclassified additional videos. In addition, after inserting the stress echocardiography review, the selection of stress echocardiography should not be reinserted and additional images or videos should be selected. For more information, see Appendix Letter to the customer and through the company service center.

Device

ULTRASOUND DIAGNOSTIC SYSTEM ACUSON SC2000, Registration 10234230166 - Serial Numbers: 400723; 40...

Manufacturer

Siemens Ltda.; Siemens AG; Siemens Medical Solutions USA, Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA