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 022 01 15 000
  • Event Initiated Date
    2015-01-05
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=6993
  • 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
    A potential problem with the vertical motor/brake assembly on the patient support/couch was discovered with a specific patient support / couch manufacturing lot, which may result in uncommanded vertical patient support/couch motion.

Device

Brilliance CT 16 Air, 64, Big Bore, ICT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core 128...
  • Model / Serial
    The following CT systems with a specific patient support / couch manufacturing lot are affected: - Brilliance CT 16 Air - Brilliance CT 64 - Brilliance CT Big Bore Oncology & Radiology - iCT - iCT SP - Ingenuity CT - Ingenuity Core - Ingenuity Core 128 - Ingenuity Flex
  • Product Description
    CT Scan
  • Manufacturer
    Philips Healthcare

Manufacturer

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