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 11 12 000
  • Event Initiated Date
    2012-11-06
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2542
  • 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 tumorloc application has the capability to generate intensity projection datasets from respiratory gated data. a circumstance has been identified where these generated datasets are flipped and incorrectly labeled left to right when they are saved to disk. this problem occurs only if all of the following circumstances are met: 1. the respiratory gated series are loaded into tumorloc along with a non-gated (free breathing) series, and 2. the data loaded into tumorloc is generated with specific patient orientations, and reconstructed with specific view conventions (see attached).

Device

Computed Tomography, TumorLOC in Brilliance CT Big Bore, Extended Brilliance Workspace (EBW), GEM...
  • Model / Serial
    TumorLOC in Brilliance CT Big Bore, Extended Brilliance Workspace (EBW), GEMINI LXL, GEMINI TF 16, GEMINI TF 64, GEMINI TF Big Bore (See attached for serial number)
  • Product Description
    X ray, Computed Tomography
  • Manufacturer
    Philips Healthcare

Manufacturer

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