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 Medical Systems.

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 089 05 13 000
  • Event Initiated Date
    2013-05-26
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=3650
  • 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 stated tolerance for ctdl 01 in the instructions for use manual did not accurately represent all systems. on some systems the measured ctdl 01 value may fall outside of these stated tolerances.

Device

Gamma Camera , Spect CT , Gemini and Precedence Systems utilizing Brilliance CT
  • Model / Serial
    Gemini Dual, Gemini 16 Power, Gemini GXL, Gemini LXL, Gemini TF 16, Gemini TF Base/Ready, Gemini TF 64, Gemini TF Big Bore. Product Code(s): 882160, 882300, 882390, 882400, 882410,882412, 882470, 882473, 882471, 882476 Precedence SPECT /CT Product Code(s): 882350, 882351 Brilliance CT (6, 10, 16, 16P, 40,64 and Big Bore), Brilliance iCT, Brilliance iCT SP Product Code(s): 728256, 728251, 728246, 728240, 728235,728231, 728243, 728244, 728306, 728311
  • Product Description
    Gamma Camera , Spect CT , Gemini and Precedence Systems utilizing Brilliance CT CT , Brilliance CT , Brilliance iCT , Brilliance iCT SP
  • Manufacturer
    Philips Medical Systems

Manufacturer

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