| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00750-1 |
| Product Name/Description |
All Carestation 750/750c Anesthesia Delivery Systems
GTIN: 00840682145596, 00840682146425, 00840682146470, 00840682146463
Software version 02SP04 or earlier
ARTG 93955
(GE Healthcare Australia Pty Ltd - Anaesthesia system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/06/2022 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare is notifying that carestation 750/750c anaesthesia delivery systems used with one of the optional auxiliary outlets [ACGO (Auxiliary Common Gas Outlet) or Auxiliary O2+AIR] could trigger a mixer failure under certain conditions. At specific O2 and total flow settings when using the auxiliary outlets, if there is an occlusion in the nasal cannula or linear circuit (e.g. due to clamping, kinking, blocked circuit, or high resistance) the mixer may enter a failure state. This will persist until the next reboot of the device.
If this mixer failure occurs, the system activates alternate O2 gas delivery (100% O2) to continue ventilation, with audible and visual alarms. Prolonged use of 100% O2 with patients that have a higher sensitivity to oxygen, such as neonates and paediatric patients, when not strictly necessary, exposes these patients to the potential risk of hyperoxia and oxygen toxicity.
To date there have been no injuries reported as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
GE Healthcare are advising customers that a software upgrade with version 02SP05 will be carried out on affected devices with ACGO configuration and pressure relief valve replacement as well as software upgrade with Version 02SP06 will be carried out on affected devices with AUXO2+AIR configuration. The corrections will be installed by December 2022.
Meanwhile customers are also advised continue to use the anesthesia system in accordance with the instructions in the User Manual and the interim actions outlined in the customer letter (will be provided only to the impacted customers by GE Healthcare).
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 659 465 - Customer Crae - GE Healthcare |