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 039 07 18 000
  • Event Initiated Date
    2018-07-05
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12874
  • 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
    It was reported that scanners running software versions 4.1.6 (brilliance ict and ingenuity ct), 4.2 (brilliance bigbore), and 4.7.0 and 4.7.2 (iqon) with the heartbeat cs pro option provide confusing information in the “impressions” section of the calcium score report. the generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time.

Device

Brilliance 64, Brilliance CT BigBore, Brilliance iCT,
  • Model / Serial
    Brilliance 64, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, and Ingenuity CT with software version 4.1.6 Brilliance CT BigBore and with software version 4.2.0 IQon Spectral CT with software versions 4.7.0 and 4.7.2
  • Product Description
    Scanning Systems, Computed Tomography
  • Manufacturer
    Philips Healthcare

Manufacturer

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