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.

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 030 09 18 000
  • Event Initiated Date
    2018-09-13
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13138
  • 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
    Philips/ respironics everflo oxygen concentrator 1102443 has the electrical rating of 230v 60hz. however, one of the components inside the device, a compressor has a label indicating 230v 50hz, please see below figure 1. the same component also has additional label on the back side, see figure 2, this second label has the correct electrical frequencies 50/60 hz. therefore, our intent is to clarify presence of the two labels and assure of safe device performance. we would like to inform our customers that the philips everflo oxygen concentrator is fully compliant to iec 60601 and sfda.Md/iec 60601-1-1, as per sfda’s national provision article six. the shipping box (package) label and device label are provided in attachment.

Device

EverFlo (Oxygen Concentrator)
  • Model / Serial
    model 1102443
  • Product Description
    Oxygen Concentrator
  • Manufacturer
    Philips

Manufacturer

Philips
  • Manufacturer Parent Company (2017)
    Philips
  • Manufacturers representative
    Philips Healthcare Saudi Arabia Ltd.
  • Source
    SFDA