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 GE 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 129 08 14 001
  • Event Initiated Date
    2014-09-10
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=6417
  • 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
    If the pdm is quickly disconnected and reconnected (a less than 10 second cycle) from a carescape bx50 monitor following a “patient discharge” or during active monitoring, the ecg waveform and its associated waveform parameters could be analyzed incorrectly.

Device

Patient Data Module (PDM) and CARESCAPE Monitor Bx50 (B850, B650, or B450)
  • Model / Serial
    The issue can occur with all versions of PDM software v2.2 or lower.
  • Product Description
    Monitors
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare