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 Siemens Healthcare Diagnostics GmbH.

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 022 06 18 000
  • Event Initiated Date
    2018-06-07
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12725
  • 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
    The purpose of this communication is to inform you of intermittent failures with the group calibration feature in dimension® software version 10.2.2. a calibration may not auto accept when performing a group calibration with more than one quality control (qc) product. if all qc levels are not processed, dimension qcc powerpak® auto acceptance for that calibration will not complete.

Device

Dimension Integrated Chemistry Systems…
  • Model / Serial
    Dimension® EXL 200 : 10636928 / Dimension® EXL with LM: 10472176 / Dimension® RxL Max: 10444828 / Dimension® RxL Max HM: 10444829 / Dimension® RxL Max HM STM: 10444831 / Dimension® Xpand® Plus: 10444837 / Dimension® Xpand® Plus HM: 10444838 / Dimension® Rx. This letter applies to Dimension systems listed in attachment running software version 10.2.2
  • Product Description
    IVDs, In vitro diagnostic devices
  • Manufacturer
    Siemens Healthcare Diagnostics GmbH

Manufacturer

Siemens Healthcare Diagnostics GmbH
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Manufacturers representative
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA