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 Elekta Inc.

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 085 04 12 000
  • Event Initiated Date
    2012-04-24
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1716
  • 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
    It is possible that the backup diaphragms drive mechanism can become loose after many years in clinical operation. this can cause a backlash between the positioning mechanism and the diaphragm. this backlash can be seen by the usual x-ray and field calibration checks when the field is moved from a small to a large field size. if there is a problem it will be that the backup diaphragm is not in the correct position behind the mlc leaf tips. if you do not do the recommended planned maintenance program, screws can become lost from the positioning mechanism. if you find one or more screws, do not use the machine for clinical operation, and find the cause.

Device

Radiology, X-ray, MLCi and MLCi2 radiation heads
  • Model / Serial
    All MLCi and MLCi2 radiation heads.
  • Product Description
    Radiology, X-ray
  • Manufacturer
    Elekta Inc

Manufacturer

Elekta Inc
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Manufacturers representative
    Analysis Device For Medical and Scientific Service ( ADMSS )
  • Source
    SFDA