| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01095-1 |
| Product Name/Description |
Vivid E9 with Software versions 112.1.0, 112.1.1, and 112.1.3
(cardiovascular ultrasound system)
Affected serial numbers: between VE94165 and VE95415
ARTG Number: 146317 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
During procedures where the 4D TEE (6VT-D) probe is used over an extended period of time, the Vivid E9 Scanner may gradually become unresponsive with the result that the Vivid E9 Scanner must be rebooted. This event may lead to possible risk to patients, when performing Transoesophageal echocardiography (TEE). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is providing a correction to be installed by a GE service engineer. End users are advised to reboot the scanner if it becomes unresponsive. A reboot should take approximately 2 minutes. |
| Contact Information |
1800 659 465 - National Call Centre |