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 Varian Medical Systems.

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 049 11 11 000
  • Event Initiated Date
    2011-11-11
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=1023
  • 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
    If the user selects the “convert to setup field” option when using the rt chart function in aria (versions 8.0 and 8.1), the dynamic multi leaf collimator (dmlc) plan components are removed in order to create an open collimator for field light setup. in the reported case (cp-03045 from the usa) a user selected this option in error and then converted the set-up field back to a treatment field. the dmlc was then missing from the resultant treatment field. if this error is not detected prior to patient treatment an open field treatment can result.

Device

COMPUTER TREATMENT PLANNING
  • Model / Serial
    ARIA RT Chart Application v8.0 and 8.1
  • Product Description
    Radiotherapy Systems, Linear Accelerator
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems
  • Manufacturer Parent Company (2017)
    Varian Medical Systems, Inc
  • Manufacturers representative
    Varian Medical Systems, Riyadh, (01) 2772126
  • Source
    SFDA