| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00802-3 |
| Product Name/Description |
Innova 2121IQ and Innova 3131IQ Cardiovascular X-Ray Imaging Systems (diagnostic fluoroscopic angiography x-ray system)
ARTG Number: 93871 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
While performing a fluoroscopic acquisition with the Innova 2121IQ or Innova 3131IQ systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover. It may happen in a very specific scenario when one operator is requesting a LIH (last image hold) functionality and another operator starts a short fluoroscopy exposure (stopping fluoroscopy exposure within 2 seconds) without waiting for the display of the LIH (last image hold) in review monitor. The user would need to restart the system in order to regain acquisition capability. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is providing work around instructions to mitigate the risk and will be implementing a software update to permanently correct the issue. |
| Contact Information |
1800 659 465 - GE Customer Care Centre |