| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01039-1 |
| Product Name/Description |
Avance, Amingo, Aisys Anaesthesia Devices (software version 8.00) and Avance CS Anaesthesia Devices (with software version 10.00)
ARTG Number: 93955 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
While operating in Pressure Control Ventilation - Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessive tidal volumes while pressure limits are maintained can result in pulmonary volutrauma and/or an increased pulmonary vascular resistance that can negatively affect cardiac filling pressure and/or stroke volume. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is providing users with work around instructions to follow until a software upgrade is provided to all customers by June 2014. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |