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 Healthcare.

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 016 05 17 000
  • Event Initiated Date
    2017-05-04
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10971
  • 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
    A small number of intellivue nmt patient cables may contain a localized isolation defect in the shielding of the acceleration sensor housing.

Device

Philips IntelliVue Neuromuscular Transmission Patient Cable
  • Model / Serial
    All Philips IntelliVue Neuromuscular Transmission (NMT) Patient Cables 989803174581 which have been manufactured between July 2012 and December 2015 are affected by this correction. This cable is used with Philips IntelliVue NMT Module 865383 and Philips IntelliVue Patient Monitors for the measurement of NMT. The 989803174581 NMT Patient Cable is also distributed as part of the 865383 IntelliVue NMT Module, Product Option #K01.
  • Product Description
    Monitoring Systems
  • Manufacturer
    Philips Healthcare

Manufacturer

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