Database updated: 2 December 2024
Safety Information
Medsafe Online Recall Database
Detail of Recall
Type of Product: | Device |
Medsafe Reference: | 29557 |
Brand Name: | Anaesthesia Work Stations |
Model: | Aisys CS2 Anesthesia Systems: P/N: 1011-9050-000 – GTIN: 00840682102292 and Avance CS2 and Avance CS2 Pro Anesthesia Systems: P/N: 1009-9050-000 - GTIN: 00840682102322 |
Affected: | |
Software version: | |
Recalling Organisation: | GE Healthcare Limited Level 7, Vero Centre 48 Shortland St Auckland 1010 |
Contact Information: | 0800 659 465 |
Manufacturer: | Datex-Ohmeda Inc |
Issue: | The manufacturer has identified that in certain Aisys CS2, Avance CS2, and Avance CS2 Pro Anesthesia Systems manufactured from January 1, 2021 to April 23, 2022 can potentially have the O2 & Air cylinder pressure transducers reversed. The anesthesia system can display the O2 cylinder pressure reading as the Air cylinder pressure and the Air cylinder pressure reading as the O2 cylinder pressure. The correct gases are connected to each supply line, but the screen will display the cylinder pressures as reversed. In rare instances prolonged hypoxia could result if the oxygen cylinder became depleted when both air and oxygen pipeline gases are unavailable and both cylinders are being utilized but not measured appropriately. |
Recall action type: | Correction |
Recall action: | Product to be modified |
Level of recall: | Hospital/Pharmacy/Laboratory |
Date Commenced: | 17/6/2022 |