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 107 10 18 000
  • Event Initiated Date
    2018-10-21
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13359
  • 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
    Philips has identified an issue with the front gantry cover from a particular supplier, which may impact the front gantry cover of your ct system. some covers from this supplier may develop a problem where the fiberglass weakens at the connection point to the gantry frame 1causing the front cover to separate from the gantry frame, allowing it to fall.

Device

Brilliance 6, Brilliance 10. Brilliance 16 & 16 Power, Brilliance 40, Brilliance 64
  • Model / Serial
    Product Name : Model Number; Brilliance 64 728231 Brilliance 40 728235 Brilliance 16 Power 728240 Brilliance 16-Slice 728246 Brilliance 10-Slice 728251 Brilliance 6-Slice 728256
  • Product Description
    Computed Tomography
  • Manufacturer
    Philips Healthcare

Manufacturer

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