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 Accuray 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 059 10 11 000
  • Event Initiated Date
    2011-10-22
  • Event Country
  • Event Source
    SFDA
  • Event Source URL
  • 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
    Accuray performed a retrofit of the synchrony camera array mounting assembly as a result of a previous report that the extension coupling worked loose and the mounting assembly unexpectedly descended. the mounting assembly weighs approximately 17 lb; unexpected contact with users or patients could result in serious injury. following the retrofit, it was found that the set screws responsible for securing the extension coupling were not tightened correctly at one site.

Device

  • Model / Serial
    C185
  • Product Description
    Radiosurgery, Camera
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturers representative
    Gulf Medical Co.
  • Source
    SFDA