Events

Safety Alert for ACUSON diagnostic ultrasound system, ACUSON S1000 models; ACUSON S2000, registration 10234230192, hazard class II, with software version VC30A, VC30B, VC30C or VC31A, batches / series: 202134; 210786; 211085; 211397; 211080.

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
    1650
  • Date
    2015-07-24
  • 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
    The potential risk pointed out by the company is an incorrect diagnosis.
  • Reason
    The doppler manual plotting tool in a full-screen format presented a possible miscalculation. the tool can incorrectly calculate the medical time rate (tav) and, consequently, incorrectly calculate the pulsatility index (pi).
  • Action
    The company directs you not to perform measurements using the Doppler trace tool in a full-screen display format. The fix of the problem will be in a software released later (update). It is necessary to share the attached Letter with the users of the equipment.

Device

ACUSON diagnostic ultrasound system, ACUSON S1000 models; ACUSON S2000, registration 10234230192,...

Manufacturer

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