Events

Safety Alert for Trade Name: E.CAM SIGNATURE SERIES; registration 10234230040; hazard class III ///// Trade Name: SYMBIA SPECT / CT EQUIPMENT; model: Symbia T; Symbia T2; Symbia T6; Symbia T16; registration 10345161973; risk class III //// Trade Name: SPECT SYSTEM; model: Symbia E; Symbia S; registration 10345161991; class of risk II

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
    1947
  • Date
    2016-05-20
  • 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
    Recommendation to users and patients: Based on the results of our risk analysis, which indicates that the possibility of error is remote, we can continue to use the system. Make sure this notice is included in the instructions for use of the system. To reduce the chances of occurrence, follow the Shutdown and Startup instructions as described in the User's Guide. We also ask clients to wait for the update schedule to correct the error mentioned in the MI002-16-S Field Action Alert Message.
  • Reason
    Siemens healthcare has determined that e.Cam or symbia systems with predictive detectors performing dynamic or gateway acquisitions may lose detector / date information.
  • Action
    Action code MI001 / 16 / S: Recommendations to users and patients ///// Software Update.

Device

Trade Name: E.CAM SIGNATURE SERIES; registration 10234230040; hazard class III ///// Trade Name: ...

Manufacturer

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