Events

Safety Alert for Trade name: ACUSON SC2000 ULTRASOUND DIAGNOSTIC SYSTEM. Technical Name: Ultrasonic Apparatus. ANVISA registration number: 10345161999. Class of risk: II. Model affected: ACUSON SC2000. Serial numbers affected: 401532

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
    1933
  • Date
    2016-06-09
  • 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: In order to avoid the problem described above, Siemens recommends that the trackball remain assigned to the colored region of interest, to the sample or pulsed or continuous wave Doppler courses, to mode M courses, to 2D field the RES region, especially when the temperature of the transducer reaches 40 ° C. However, if the problem occurs, we recommend the following actions: Temporarily increase or decrease the transmission energy OR wait for the temperature of the transducer to reach 41ºC. 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
    Siemens healthcare sa advises that when purchasing images with a transesophageal transducer (tee) (z6ms, v5ms or v7m), there may be loss of ability to control the color region of interest, the sample or the pulsed or continuous wave doppler cursor , the m cursor, the 2d field of view, or the res region of interest with the trackball.
  • Action
    Field action code US013 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos treats of sending Letter to the Client with the guidelines of how to proceed. (Attachment)

Device

Trade name: ACUSON SC2000 ULTRASOUND DIAGNOSTIC SYSTEM. Technical Name: Ultrasonic Apparatus. ANV...

Manufacturer

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