Field Safety Notices about Aisys CS2, Aisys, Avance CS2, Avance, Amingo, Aespire and Aestive

According to Agency for Medical Products and Medical Devices of Croatia, this field safety notices involved a device in Croatia that was produced by Datex-Ohmeda.

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
    Field Safety Notice
  • Event ID
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, 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 Croatia.
  • Extra notes in the data
    The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Datex-Ohmeda, Inc. (GE Healthcare) reminding users on the importance of occasional device shutdown/restarting and self-testing at restarting.
    The manufacturer reminds users that devices start alarm for shutdown/restarting due to self-testing, if devices work continuously longer than 12 hours and may stop working if they are continuously on longer than 49 days.
    Here you may view the safety information addressed to users.