Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by SIEMENS.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 088 07 12 000
  • Event Initiated Date
    2012-07-23
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2123
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    The issue is isolated images of pixel depth greater than 12 bit (99% of all stored images). problem exists prior to va20d as well" analysis showed that this behaviour is caused by a software bug. in some situations it can happen that a miscalculation is done for the grey scale values in the functions "region of interest", "pixel lens", "edge enhancement" and "histograms". the min/max value of pixel density in the functions "region of interest", "pixel lens", "edge enhancement" and "histograms" is not correct for images with a pixel depth greater than 12 bit. it has to be noted that the mentioned measurements shown in prior images are also not correct. all values which are calculated for images with a pixel depth less than or equal to 12 bits are correct.

Device

Picture archiving and communication system, radiology, Syngo. Plaza and Syngo Imaging XS
  • Model / Serial
    (1) System Label 10592 457 System version:VA20D (2) System Label104 96 279 System version:All versions VA70 and higher are affected
  • Product Description
    picture archiving and communication system
  • Manufacturer
    SIEMENS

Manufacturer

SIEMENS
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Manufacturers representative
    Siemens Medical Solutions, Jeddah, (02) 6602933
  • Source
    SFDA