Events

Safety Alert for ACUSON Diagnostic Ultrasound System. Model: ACUSON S2000. Anvisa Registry n ° 10234230192.

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..

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
    1673
  • Date
    2015-09-01
  • 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
    The problem occurs when using the CIVCO biopsy connectors in combination with the ACUSON S Family screen orientations. The biopsy needle path may not correspond to the screen orientations and this occurs on the 6C1 HD and 18L6 HD transducers. The potential risk is not to obtain the tissue sample of interest. To avoid this problem, do not use the 6C1 HD and 18L6 HD transducers with the CIVCO biopsy connectors for guided biopsy procedures. For guided procedures with other transducers, follow the instructions given by Siemens in your customer letter, available at: http://portal.anvisa.gov.br/wps/wcm/connect/50122e8049b158f3a2adaada875a0177/Carta+Portugu%C3%AAs+ US016-15-S.pdf? MOD = AJPERES
  • Reason
    A problem may occur when using the civco biopsy connectors in combination with the acuson s family on-screen guidance. the path of the biopsy needle may not match the orientation of the screen. this may occur on 6c1 hd and 18l6 hd transducers.
  • Action
    Information letter to customers, informing about the restriction of the use of 6C1 HD and 18L6 HD transducers with CIVCO biopsy connectors.

Device

ACUSON Diagnostic Ultrasound System. Model: ACUSON S2000. Anvisa Registry n ° 10234230192.

Manufacturer

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