| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00018-1 |
| Product Name/Description |
Innova 3100, Innova 3100IQ and Innova 2100IQ Cardiovascular X-ray Imaging Systems
System ID Numbers: 0910162006, 0910163011 and 0910064007
ARTG Number: 93871 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
The Innova system can unexpectedly stop delivering X-rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. No injuries have been reported due to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising users to ensure the Innova system emits x-rays before starting any procedure by completing a quick system functional check. If the system displays an "X-ray not available" error message, GE is advising users to reset the system. GE Healthcare will be correcting all affected systems. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |