| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00014-1 |
| Product Name/Description |
PET Discovery 600 and PET Discovery 690, with software versions pet_mict_plus.44 and pet_velocity.53 (Nuclear medicine diagnostic system)
ARTG Number: 156649 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of the Discovery 600 and Discovery 690. A software issue exists when using List Mode Replay, such that subsequent reconstructions with that data could contribute to an image with scatter over-estimation and overcorrection. Reconstructed images with this issue will have many fewer counts than the acquired scan data and a high scatter fraction. This issue may affect studies that use List Mode Replay and are reconstructed after subsequent acquisitions and may lead to image misinterpretation and/or inaccurate treatment decisions. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
To avoid this potential issue, GE Healthcare is advising customers to implement temporary workaround instructions through the customer letters. GE Healthcare will provide a software update for all affected systems to address the issue permanently. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |