Events

Safety Alert for ULTRASOUND DIAGNOSTIC SYSTEM ACUSON SC2000, Registration 10234230166 - Serial Numbers: 400294; 400723; 400758; 400762; 400831; 401532; 401704; 401809.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Ltda.; Siemens Medical Solutions USA, Inc.; 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
    1690
  • Date
    2015-09-19
  • 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 informs that the potential risk is that the study data, including the measurements, are not captured and the study has to be performed again, extending the examination time to reacquire lost data and, in this case, the patient can be given extra dose of lidocaine or dobutamine.
  • Reason
    Siemens healthcare informs that the acuson sc2000 ultrasound system considers case / patient differences in the same patient name as unique occurrences of patients when registered on the same ultrasound system. the system recovers the sensitivity of uppercase and lowercase letters even though the original study has been removed from the hard disk. if these differences are not corrected at registration, the system will not capture images or clips.
  • Action
    Siemens Healthcare recommends correcting case / patient case differences in patient name at the time of patient registration in order to avoid this problem. More information - Letter to the Client

Device

ULTRASOUND DIAGNOSTIC SYSTEM ACUSON SC2000, Registration 10234230166 - Serial Numbers: 400294; 40...

Manufacturer

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