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.

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 150 10 18 000
  • Event Initiated Date
    2018-10-31
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13406
  • 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
    Siemens healthcare diagnostics has identified an issue with dimension vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination.

Device

Dimension Vista Intelligent Lab Systems
  • Model / Serial
    Dimension Vista Intelligent Lab Systems with Software v.3.7 or v.3.8.1. An in vitro diagnostic medical device (IVD) Dimension Vista 500 Intelligent Lab System Siemens Material Number (SMN): 10488217 and 10488224 Dimension Vista 1500 Intelligent Lab System Siemens Material Number (SMN): 10444802 and 10459469
  • Product Description
    Instrument/analyser IVDs
  • Manufacturer
    SIEMENS

Manufacturer

SIEMENS
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Manufacturers representative
    Siemens Medical Solutions, Jeddah, (02) 6602933
  • Source
    SFDA