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 098 04 14 000
  • Event Initiated Date
    2014-04-16
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=5681
  • 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
    Risk of battery failure increases with age, when a battery remains in use longer than 3 years after the date of manufacture or 500 charge-discharge cycles. such failure may result in overheating. overheating of the battery may cause the battery to ignite or explode, which may result in injury to a patient or user.

Device

Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors
  • Model / Serial
    The following IntelliVue Patient Monitors with software releases up to and including G.0(SW B.0/B.1/C.0/D.0/E.0/F.0/G.0) containing battery operation. Model Number MP2, Product Numbers M3002A Model Number X2, Product Numbers M8102A Model Number MP5, Product Numbers M8105A Model Number MP5, Product Numbers M8105AT Model Number MP20, Product Numbers M8001A Model Number MP30, Product Numbers M8002A Model Number MP40, Product Numbers M8003A Model Number MP50, Product Numbers M8004A
  • Product Description
    Monitors, IntelliVue Patient Monitors
  • Manufacturer
    Philips Healthcare

Manufacturer

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