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 137 02 18 000
  • Event Initiated Date
    2018-02-27
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12216
  • 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
    Upon closing the emergency stop (e-stop) the system performs an internal check. as a result of the motion controller in the couch, there is a delay in the response to the internal check. this delay may cause the couch carbon top to enter a free float state, which may allow it to move during patient load or unload activities. this free float motion results in the estop being opened due to the unexpected couch motion.

Device

Ingenuity Flex, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance iCT, Brilliance iCT S...
  • Model / Serial
    Ingenuity Flex - 728317 Ingenuity CT - 728326, 728325 Ingenuity Core - 728321 Ingenuity Core128 - 728323, 728324 Brilliance iCT - 728306 Brilliance iCT SP - 728311 Brilliance Big Bore (Oncology) - 728243 Brilliance Big Bore (Radiology) - 728244 Brilliance 16 Slice (Air) - 728246 Brilliance 16 Slice (Power) - 728240 Brilliance 40 - 728235 Brilliance 64 - 728231 IQon Spectral CT - 728332 Brilliance 6 Slice (Air) - 728256 Brilliance 10 Slice (Air) – 728251 Brilliance CT Private Practice CV config. - 728241
  • Product Description
    Scanning Systems, Computed Tomography
  • Manufacturer
    Philips Healthcare

Manufacturer

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