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 Nucletron bv.

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 088 05 11 000
  • Event Initiated Date
    2011-05-29
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=450
  • 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
    Investigation by the manufacturer showed that in the service mode the “source alignment procedure” could be started with the door physically open. the door interlock only triggers if the door is closed prior to alignment. the alignment can also be done with the doorswitch on linac . if set to linac , the door interlock to the hdr will always be seen by flexitron as being open. in the source alignment mode of the flexitron, the firmware does not look at the state of the door interlock but only to the state-change ( from closed to open). in this case the ir192 –source was thus not automatically retracted into the vault of the apparatus when opening the door of the irradiation bunker as the door switch only works in clinical mode.

Device

FLEXITRON HDR 40 CH(Diagnostic and therapeutic radiation device)
  • Model / Serial
    Software version: TDU (Treatment Delivery Unit): v 1.1.0 TCC ( Treatment Communication console ) : 1.2.1 Serial No: SYS00003
  • Product Description
    Brachy therapy after loader, The Flexitron Remote After loader System enables an operator to remotely apply a radionuclide source (Ir192) into the body or to the surface of the body for radiation therapy. The Flexitron system is intended to be used in combination with applicators which make it suitable for intracavitary, interstitial,intralumenary, bronchial, endovascular, intra-operative and surface brachytherapy.
  • Manufacturer
    Nucletron bv

Manufacturer

Nucletron bv
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    SFDA