Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19945 |
| Brand Name: | GE Anaesthesia Work Stations |
| Model: | |
| 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: | It has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices. Aisys CS2 anesthesia devices and upgraded Aisys anesthesia devices deliver a momentary, self-correcting increase of the anesthetic agent, affecting the inhaled and exhaled concentrations for a short time, upon either of the following setting changes: A fresh gas setting change from 95%-25% oxygen to only air (21% oxygen). Any total flow setting change while using 21% oxygen (air only). The momentary bolus of anesthetic agent will not occur with nitrous oxide as the carrier (balance) gas or if the oxygen concentration is set above 21% (air only). Delivery of this momentary bolus of anesthetic agent is potentially hazardous because it could lead to hypotension in certain vulnerable pediatric patients when 21% oxygen (air only) is used. There have been no injuries re ported of this issue. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 24/3/2016 |
