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 TomoTherapy Incorporated.

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 068 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=4&rid=665
  • 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
    During dicom export of plan level images with a non square exported field of view (fov), an anomaly in the process of squaring the plan level image may cause the image to shift with respect to rois and dose. when the anomaly occurs, the magnitude of the image shift can be a full iec-x voxel, a full iec-z voxel, or full voxels in both iec-x and iec-z.

Device

Hi-Art DICOM System
  • Model / Serial
    Hi·Art versions 4.0.x, and HD versions 1.0.x
  • Product Description
    Radiotherapy: treatment planning system.
  • Manufacturer
    TomoTherapy Incorporated

Manufacturer

TomoTherapy Incorporated
  • Manufacturer Parent Company (2017)
    Accuray Inc
  • Manufacturers representative
    Gulf Medical Co. Jeddah (02) 6512828
  • Source
    SFDA