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 114 01 13 000
  • Event Initiated Date
    2013-01-28
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2950
  • 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 philips heartstart xl+ defibrillator/monitor may fail to power on in clinical mode and instead, power on in service mode displaying an “equipment disabled: therapy” prompt, requiring the user to enter a password and perform an operational check to clear the condition. the device will not return to clinical mode until an operational check is performed.

Device

Philips HeartStart XL+ Defibrillator/Monitor
  • Model / Serial
    model number 861290 Units Affected: Units manufactured by Philips from October, 2011 to January 2013, and shipped worldwide with serial numbers within the ranges: USO1100100 – USO1100372 USN1100376 – USN1100960 USD1100961 – USD1101095 US11201096 – US11201186 US21201187 – US21201239 US31201240 – US31201537 US41201538 – US41201585 US51201586 – US51201721 US61201722 – US61201924 US71201925 – US71202048 US81202049 – US81202168 US91202169 – US91202514 USO1202515 – USO1202990 USN1202991 – USN1203537 USD1203538 – USD1203968 US11303969 – US11303972
  • Product Description
    Defibrillator/Monitor
  • Manufacturer
    Philips Healthcare

Manufacturer

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