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 057 07 17 000
  • Event Initiated Date
    2017-07-12
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11301
  • 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
    Issue 1: scan parameters exceeds system resources issue 2: scan may start at the top of the head, which may not be where the operator is expecting the scan to start issue 3: error message appears stating: “the exam application stopped working” and will instruct the operator to close the program issue 4: during a bolus tracking procedure, after acquiring the surview, locator and tracker, the scanner may move into place, give the patient breathing instructions, and then fail to acquire the scan issue 5: image volumes are not found in patient directory when thin images are included in one of the multiple results issue 6: application may fail when modifying the results plan box during 3d calcium score issue 7: tube too hot issue 8: memory overflow issue 9: while the reconstruction is in progress disconnecting the recon box (cirs) may not give error message issue 10: in the plan viewer if the start position is modified the total length of the acquisition will change as well.

Device

Philips Brilliance iCT
  • Model / Serial
    Brilliance ICT SP (728311) Brilliance 1CT (728306) Software Issues in 4.1.6
  • 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