Events

Safety Alert for Trade name of the product: SYMBIA MARCA SIEMENS SPECT / CT EQUIPMENT (registration number: 10345161973); SPECT SYSTEM (registration number: 10345161991), E.CAM SIGNATURE SERIES MARK SIEMENS (registration number: 10234230040) /// affected lots: see file "Product description MI002 / 16 / S.pdf" / / Product risk class : II and III.

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
    1879
  • Date
    2016-04-21
  • 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
  • Reason
    The company "has determined that e.Cam or symbia systems with predictive detectors performing dynamic or gateway acquisitions may lose detector date / time information." research shows that "the resulting risk is that the image data frame and the ejection fraction value calculated are smaller. although erroneous diagnoses are a possibility, if ejection fraction values ​​are used as the sole source of diagnosis, we were not informed of such events. ".
  • Action
    Field classification: letter to client /// Field action code: MI002 / 16 / S /// Recommendations to users and patients: one can continue to use the system; make sure that this warning is included in the instructions for use of the system. We also ask that customers await the release of the update that aims to correct the error mentioned in this field action. To reduce the chances of occurrence, follow the Shutdown and Startup instructions as described in the User's Guide.

Device

Trade name of the product: SYMBIA MARCA SIEMENS SPECT / CT EQUIPMENT (registration number: 103451...

Manufacturer

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