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.

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 070 10 15 000
  • Event Initiated Date
    2015-10-20
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8385
  • 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
    Issue 1: image position accuracy issue 2: tracker image artifact issue 3: ring-dot image artifact.

Device

Brilliance 16-Slice (Air), Brilliance 64 CT, Ingenuity Core, Ingenuity Core 128, Brilliance CT Bi...
  • Model / Serial
    Those issues are software related. To determine whether your system is affected, you must have one of the following systems and an affected software version: Issue 1: Image Position Accuracy issue due to Image Rotation Calibration Software Error on : Brilliance 16-Slice (Air), Brilliance CT Big Bore, Ingenuity Flex Issue 2: Tracker Image Artifact issue due to Reconstruction Software Error on : Brilliance 16-Slice (Air), Brilliance 64 CT, Ingenuity Core, Ingenuity Core 128, Brilliance CT Big Bore, Ingenuity Flex Issue 3: Image Artifact issue due to X-ray Measurement Firmware Error on : Brilliance 64 CT, Ingenuity Core, Ingenuity Core 128 All Issues: affected software versions: 3.6.1, 3.6.2, 3.6.4, 3.6.5
  • Product Description
    CT scanner
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Manufacturer Parent Company (2017)
    Philips
  • Manufacturers representative
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA