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 098 12 13 000
  • Event Initiated Date
    2013-12-11
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=4960
  • 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 pet reconstruction server (prs) database may lock up after a ct acquisition is completed and before a pet acquisition is started on gemini te 16, gemini tf 64, gemini tf big bore, truflight select, gemini tf ready and gemini lxl pet/ct systems.

Device

GEMINI TF 16, GEMINI TF 64, GEMINI TF Big Bore, TruFlight Select, GEMINI TF Ready and GEMINI LXL ...
  • Model / Serial
    GEMINI TF PET/CT 16 and GEMINI TF PET/CT 64 Software Version 3.5.1, GEMINI TF PET/CT 16 and GEMINI TF PET/CT 64 Software Version 35.1.1, GEMINI TF PET/CT 16, GEMINI TF PET/CT 64, GEMINI TF Ready and GEMINI LXL Software Version 3,5.2, GEMINI TF PET/CT 16 and GEMINI TF PET/CT 64 Software Version 3.5.2.1, GEMINI TF Big Bore Software Version 3.6;, GEMINI TF Big Bore Software Versions 3.6.1 and 3.6.2, TruFlight Select systems Software Version V3.5.3
  • Product Description
    PET Reconstruction Server (PRS) database
  • Manufacturer
    Philips Healthcare

Manufacturer

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