Events

Safety Alert for Image Archiving and Communication System - PACS, Model Syngo Imaging XS; Registration 10234230146, Serial Numbers: Annex to the alert.

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
    1485
  • Date
    2014-12-11
  • 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 an invalid printer combination and the syngo Imaging XS printer conversion file may cause incorrect anatomical size printing.
  • Reason
    Prints can be printed at incorrect anatomical size if you use the syngo imaging xs film application to print at anatomical size with a printer not suitable for anatomical printing. this can happen due to an invalid printer combination and the syngo imaging xs printer conversion file.
  • Action
    The company advises customers to calculate the distance measured in the print through the scale contained in the right-hand end of the print. The distance between two graduation lines corresponds to one centimeter in the anatomy represented. If anatomical printing is unsuitable contact your Regional Representative for proper printer information. Siemens recommends retaining the letter with the laboratory records and forwarding the notification to anyone who may have access to the products.

Device

Image Archiving and Communication System - PACS, Model Syngo Imaging XS; Registration 10234230146...

Manufacturer

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