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 Philips Healthcare Gamma Cameras.

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 086 08 17 000
  • Event Initiated Date
    2017-08-24
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11452
  • 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
    In order to save archiving space, the allura xper r9 systems and azurion r1.1 systems include the option of downscaling the image when exporting images to the external dicom destination (e.G., pacs). when using the downscale option, the measurements performed with the allura r9 system or azurion r1.1 system using the qa basic measurement tool will not be correctly exported to the external dicom destination. the difference between the original measurement and the exported measurement can vary. the distance value after export is factor 1 to 4 smaller than the original value. the difference will depend on the acquired image (e.G., x-ray protocol, field of view) and the used archive settings (i.E., downscale settings).

Device

Allura Xper R9 and Azurion R1.1
  • Model / Serial
    Allura Xper R9 and Azurion R1.1 systems with the QA Basic Measurement tool. Product names: Allura Xper R9 7M12, Allura Xper R9 7M20, Azurion 7M12; Azurion 7M20; Azurion 3M12; Azurion 3M15
  • Product Description
    imaging systems
  • Manufacturer
    Philips Healthcare Gamma Cameras

Manufacturer

Philips Healthcare Gamma Cameras
  • Manufacturer Parent Company (2017)
    Philips
  • Manufacturers representative
    Philips Healthcare Saudi Arabia Ltd.
  • Source
    SFDA