Events

Safety Alert for Syngo.Plaza Image Archiving and Communication System (PACS), Risk class I, Affected serial numbers: 100382; 100180; 100193; 100220; 100222; 100232; 100254; 100313.

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

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
    1599
  • Date
    2015-06-03
  • 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
    According to the record holder, when there is a series captured by the software with missing images, the software makes it impossible to save the file. The upgrade was performed remotely except for equipment serial number 100254.
  • Reason
    The software update aims to improve the performance and correction of image storage (missing images).
  • Action
    The registry holder will update the software by scheduling. The customer can continue to use the system while waiting for the on-site scheduling and update.

Device

Syngo.Plaza Image Archiving and Communication System (PACS), Risk class I, Affected serial number...

Manufacturer

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