Events

Safety Alert for ULTRASOUND DIAGNOSTIC SYSTEM ACUSON SC2000. ANVISA registration no. 10345161999. Risk class II. Serial numbers: 401704 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
    1846
  • Date
    2016-04-01
  • 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
    In case the reported problem occurs when the wheels are in the "unlocked" position and the user attempts to move the system, he may lose his balance. If the wheels are in the "locked" position and the user attempts to move the system, he may suffer damage or injury to the soft tissue.
  • Reason
    Siemens healthcare diagnósticos sa informs that the metal component used to engage the wheel lock can disconnect, preventing the user from locking and unlocking or steering the wheels.
  • Action
    The field action code US035 / 15 / S initiated by Siemens deals with a field correction, parts and parts correction, with risk classification III (situation in which there is a low probability that the use or exposure to a health adverse health consequences). Recommendation to users and patients: Until the necessary repairs have been completed on your system, share this information with all employees in your health care facility who need to be aware of this problem.

Device

ULTRASOUND DIAGNOSTIC SYSTEM ACUSON SC2000. ANVISA registration no. 10345161999. Risk class II. S...

Manufacturer

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