Events

Safety Alert for ARCHIVING AND IMAGE COMMUNICATION SYSTEMS (PACS) SYNGO IMAGING AND SYNGO PLAZA. Anvisa Registrations n ° 10234230146 (Syngo Imaging) in ° 10234230177 (Syngo Plaza).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Ltda..

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
    1194
  • Date
    2012-10-22
  • 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
    Additional information in the Alert Messages released by Siemens, available at: http://portal.anvisa.gov.br/wps/wcm/connect/92c13f004d2ced31ae03fe4031a95fac/Messagem_de_Alerta_Syngo_Plaza.pdf?MOD=AJPERES and http://portal.anvisa.gov .br / wps / wcm / connect / 1d3081004d2cece7addcff4031a95fac / Message_of_Alerta_Syngo_Imaging.pdf? MOD = AJPERES
  • Reason
    Incorrect pixel density value for images with a pixel depth greater than 12 bits. the problem affects the "region of interest", "pixel lens", "edge enhancement" and "histograms" functions.
  • Action
    The company is developing a new software version (Syngo Imaging XS VA70B_0113) to solve the problem, which should be available until March 2013. Until the problem is corrected you should not use the functions mentioned above for images with a depth of pixels larger than 12 bits. Let the operators know about the problem and fix a warning near the location of data acquisition / manipulation (images), informing about the restrictions of use of the system.

Device

ARCHIVING AND IMAGE COMMUNICATION SYSTEMS (PACS) SYNGO IMAGING AND SYNGO PLAZA. Anvisa Registrati...

Manufacturer

Siemens Ltda.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA