Events

Safety Alert for DIAGNOSTIC ULTRASOUND SYSTEM, model ACUSON SC2000 -. registry 10345161999 - Class of risk II. Serial Numbers: 400758; 400762; 400831; 400723 and 401809.

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 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
    1811
  • Date
    2016-02-03
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    When registering the patient's name on the acuson sc2000 ultrasound system, case / patient differences are considered when describing the patient name. if the differences are not corrected at registration, the system will not capture the images or clips with a potential risk that the study data, including the measurements, will not be captured and the study must be performed again, extending the examination time to reacquire missing data.
  • Action
    Software update. Action code US030 / 15 / S and US031 / 15 / S. //////////// Recommendation to users and patients: the user should file all patient data before the software update starts. ///////// In addition, while updating software is not performed, the recommendation of Portuguese Letter US024 / 15 / S is maintained, which says: in order to avoid the problem of registering the patient's name, the user must correct the differences in uppercase / lowercase letters in the patient's name at the time of registration.

Device

DIAGNOSTIC ULTRASOUND SYSTEM, model ACUSON SC2000 -. registry 10345161999 - Class of risk II. Ser...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Medical Solutions USA, Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA