Defect: Aisys CS2/Avance CS2/Avance CS2 Pro Anaesthesia Systems, switched O2/air pressure reading

A product defect correction has been issued for the following systems manufactured by Datex-Ohmeda and sold by GE Healthcare:

  • Aisys CS2 Anaesthesia Systems: P/N: 1011-9050-000 – GTIN: 00840682102292
  • Avance CS2 and Avance CS2 Pro Anaesthesia Systems: P/N: 1009-9050-000 - GTIN: 00840682102322

The above models, manufactured between 1 January 2021 and 23 April 2022, can potentially have the O2 and air cylinder pressure transducers reversed. The system can display the O2 cylinder pressure reading as the air cylinder pressure and vice versa. The correct gases are connected to each supply line, but the screen will display the cylinder pressures as reversed.

There is a risk the cylinder in use could become depleted without the knowledge of the anaesthetist operating the system. In rare instances, if both cylinders are in use and no pipeline gases are available, a patient could experience prolonged hypoxia.

The manufacturer has provided instructions for continuing to use the system safely, in a letter to affected owners.

For more information, see the Therapeutic Goods Administration Australia recall listing or the Medsafe New Zealand recall listing.

Last updated 09:00 25.07.2022