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 027 11 11 000
  • Event Initiated Date
    2011-11-09
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1001
  • 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 carescape monitor b650 may freeze in the middle of the start-up sequence, or enter into a continuous reboot cycle, preventing the normal use of the patient monitor. this may happen during monitor start-up by the operator or during patient monitoring. the carescape monitor b650 may lose audible alarms and qrs beep tone if the monitor is connected to an external information or data collection system via a usb port, and the user disconnects the usb cable from the patient monitor. in this situation, the monitor does not provide any indication that it cannot sound audible alarms. the audible alarms are re-enabled only after the monitor has been manually restarted by the operator.

Device

Electrocardiography, CARESCAPE Monitor
  • Model / Serial
    Model: B650 V1.1.8 and earlier
  • Product Description
    Monitors, Bedside, Electrocardiography
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare