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 CMS Inc Div Elekta AB.

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 070 07 11 000
  • Event Initiated Date
    2011-07-18
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=667
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    The xio software currently prompts users to enter ct to electron density data for a study set. electron density should be used for photon and electron calculations. proton broad beam and pencil beam calculations should use relative stopping power and proton spot beam calculations should use mass density. no indication is given that electron density data should only be used for photon and electron calculations and that either relative stopping power or mass density should be used for proton calculations (depending on the algorithm). use of electron density instead of mass density could result in errors of up to 5% for dense bone and up to 8% for densities greater than 2 gm/cm3. the problem occurs when defining a ct to ed table in xio and has existed since xio release 2.4.0, however it only affects xio sites with machines capable of creating protons for treatment.

Device

Radiation therapy, Treatment planning system software, application program, XiO
  • Model / Serial
    XiO versions equal to or greater than 2.4.0 and less than 4.63.0
  • Product Description
    Radiation, Treatment, Planing, Workstation
  • Manufacturer
    CMS Inc Div Elekta AB

Manufacturer

CMS Inc Div Elekta AB
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Manufacturers representative
    Al-Faisaliah Medical System, Riyadh, (01) 2119999
  • Source
    SFDA