| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01326-1 |
| Product Name/Description |
GEMINI TF 64 PET/CT Systems, software versions 3.5.1 and 3.5.2.1
ARTG Number: 118077 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study. If this condition occurs, users cannot remedy this issue and will require service interaction prior to the system being operational. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is contacting all affected customers to schedule service by a Field Service Engineer to install a software update to correct the problem. This action has been closed-out on 12/02/2016. |
| Contact Information |
1800 251 400 - Phillips Customer Care Centre |