Events

Safety Alert for SPECT / CT EQUIPMENT SYMBIA, SIEMENS BRAND, Model Symbia T; Registration 10234230128 - Serial Numbers 1041; 1057; 1058; 1124; 1200; 1171; 1156; 1202; 1238; 1215 and 1286.

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 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
    1487
  • Date
    2014-12-12
  • 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 record holder informs that use of the equipment may cause the gantry to loosen or detach the mounting plates.
  • Reason
    Siemens is performing this field correction to replace the rotating motor of the mounting plate. replacement is due to cracks in the rubber damper within the assembly assembly, which can cause loosening or separation of the mounting plates in the gantry. this new mounting plate includes significant improvements in rubber shock absorbers for stability of the assembly.
  • Action
    The company directs the customer to wait for the inspection of the system by the Service Team and to file the letter with the Operator's Manual.

Device

SPECT / CT EQUIPMENT SYMBIA, SIEMENS BRAND, Model Symbia T; Registration 10234230128 - Serial Num...

Manufacturer

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