| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00326-1 |
| Product Name/Description |
Optima CT660, Brivo CT385, Discovery PET/CT 610 and Discovery PET/CT 710 Systems
(when used with certain PACS systems)
ARTG Number: 156650 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
There is an issue related with the Direct Multi-Planar Reformat (DMPR) function and Screen Saved Images on the scanner. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some picture archiving and communication system (PACS) may combine series under a patient using only the Series UID, although all images are correctly annotated. This issue can cause additional images from a different patient and images from two or more patients to appear in one exam. Please note that this issue has only been seen on PACS systems manufactured by Intelerad (IntelePACS 4-3-1-P350 and InteleBrowser -4-3-1-P350) at this time. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is recommending that customers discontinue using the DMPR functionality, if they are using the above PACS version or if they see similar issues from their current PACS and utilise an alternative capability, such as Batch-mode Reformat on the GE AW, AW server or scanner operator console or 3D reformat save on their 3D PACS viewer. GE Healthcare is planning to implement the permanent correction to affected systems when it is available. |
| Contact Information |
1300 722 229 - GE National Service and Support Centre |