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 066 09 17 001
  • Event Initiated Date
    2018-02-06
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12088
  • 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
    Some suresigns vsi, vs2+ products have the date of manufacture on its serial number label as “%dom”, instead of the specific date in the format of yyyy-mm.

Device

SureSigns VSi, SureSigns VS2+ monitors
  • Model / Serial
    Model: SureSigns VSi - NBP Product: 863275 Serial Numbers: See Attached Model: SureSigns VSi - NBP/SPO2 Product: 863276 Serial Numbers: See Attached Model: SureSigns VSi - NBP/SPO2/Temp/Wireless Product: 863277 Serial Numbers: See Attached Model: SureSigns VS2+ NBP/SPO2 Product: 863278 Serial Numbers: See Attached Model: SureSigns VS2+ NBP/SPO2/Wireless Product: 863279 Serial Numbers: See Attached
  • Product Description
    Patient Monitor
  • Manufacturer
    Philips Healthcare

Manufacturer

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