| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01265-1 |
| Product Name/Description |
PET Discovery 610 and Discovery 710 with software version pet_coreload.44 and pet_mfk.44
ARTG Number: 156650 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
A software issue exists when using List Mode Replay feature, such that subsequent reconstructions with that data could contribute to an image with scatter over-estimation and overcorrection artifacts which may be presented as 'black background' and creates an apparent perfusion defect. 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. This issue may lead to image misinterpretation and/or inaccurate treatment decisions. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is providing users with work around instructions to follow as an interim measure. A software upgrade will be performed as a permanent fix. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |