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 133 07 18 000
  • Event Initiated Date
    2018-07-26
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12973
  • 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
    On systems equipped with the auxiliary common gas outlet (acgo), there is a potential for the auxiliary gas switch to unexpectedly switch from the acgo position back to the circle position. on systems equipped with the aux o2 + air function the switch could unexpectedly switch from the aux o2 + air position back to the circle position. these situations could lead to hypoxia.

Device

arestation 620/650/650c A1, Carestation 620/650/650c A2, Carestation 30 and 9100c NXT Anesthesia ...
  • Model / Serial
    Carestation 620 A1 (GTIN: 00840682103985) Carestation 650 A1 (GTIN: 00840682103947) Carestation 650c A1 (GTIN: 00840682103954)
  • Product Description
    Anesthesia Systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare