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 015 10 12 000
  • Event Initiated Date
    2012-10-08
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2460
  • 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
    1. when translating the calcium scoring (cs) results into chinese, the percentile is not reported accurately. 2. in the calcium scoring (cs) protocol, the protocol is switched to mass score but the protocol name remains agatston. 3. spline measurement values do not update when adding control point (cp) and when changing the length of the line. 4. in the ct viewer (ctv) pet studies being loaded from remote with slope different than 1, appear incorrectly in 2d scene and are not displayed with the correct suv values. 5. loading pet images in the ct viewer (ctv) \ quick review from remote with slope different than 1, the images with the different slope appear incorrectly with wrong suv values in perception and in qr.

Device

Computed tomography system, Extended Brilliance Workstation (EBW)
  • Model / Serial
    Extended Brilliance Workstation with running software version(s) 4.0.2, V4.5.2 or V4.5.3
  • Product Description
    Computed tomography system
  • Manufacturer
    Philips Healthcare

Manufacturer

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