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 010 07 14 000
  • Event Initiated Date
    2014-07-02
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=6083
  • 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 received a report from the field that the fpd failed to remain securely locked in the deployed position. during a daily xct quality assurance phantom scan for image quality and hounsfield unit (hu) linearity an operator experienced resistance when engaging the locking handle of the fpd in the deployed position. with the locking handle in the locked position, the fpd locking mechanism was not locked, moved unexpectedly and contacted the imaging detector during system movement. philips’ investigation determined the internal linkage shaft broke preventing the fpd from being locked into its correct deployed position.

Device

BrightView XCT and BrightView X- upgraded with the XCT Flat Panel Detector
  • Model / Serial
    - BrightView XCT - BrightView X- upgraded with the XCT Flat Panel Detector (FPD)
  • Product Description
    SPECT/CT System
  • Manufacturer
    Philips Healthcare

Manufacturer

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