| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00210-1 |
| Product Name/Description |
INNOVA 2121IQ (Cardiovascular X-ray imaging system)
Serial Number 589404BU3
ARTG Number: 93871 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
The Innova system may not boot up properly after a power-on or after a system reset. Additionally it may shut down unexpectedly during an exam which may result in the total loss of real-time interventional imaging. The loss of the fluoro imaging capability may cause substantial harm to a patient, in case it happens during a "sensitive phase" of a coronary intervention. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising users to ensure a quick functional check is performed before use. GE will be correcting all affected systems. |
| Contact Information |
1800 659 465 - GE Heathcare National Call Centre |