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 Philips 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 106 10 18 000
  • Event Initiated Date
    2018-10-21
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13358
  • 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
    Kv/ma lockin not functioning as specified: the lock-in function is a fluoroscopy only function. when this function is enabled, the current radiation parameters, (kv and ma values), are retained to keep a consistent image impression. this is relevant for examinations of anatomies such as knee or shoulder, where the amount of dose at the detector is strongly influenced by the amount of direct radiation. due to a software bug, the ma values are not locked, but increase when the operator restarts pulsed fluoroscopy several times after activation of the lock-in function. as a result, the patient received an increased radiation dose stitching with skyplate aborts after first image: if there is an improper synchronization between the skyplate detector and the system, the preview offset image will have artifacts. if this happens, the system software identifies the preview image buffer as not usable during the first part image acquisition of the stitching run and as a result will abort the run. the stitching run has to be repeated.

Device

CombiDiagnost,
  • Model / Serial
    All CombiDiagnost systems with software version 1.0.0, 1.0.1 and 1.0.2
  • Product Description
    CombiDiagnost
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Parent Company (2017)
    Philips
  • Manufacturers representative
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA