| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00576-1 |
| Product Name/Description |
Brilliance CT 64-Channel with Essence Technology, Ingenuity Core, Ingenuity Core128 and Ingenuity CT, software versions v4.1.3, v4.1.4 and 4.1.5 (used for diagnostic computed tomography scanning)
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
The following issues have been identified which may result in additional patient scanning and threfore additional radiation doses. There have been no reports of injuries as a result of these issues;
- Sagittal result shortened for axial head scans.
- When axial images are acquired with a gantry tilt, the scan increment is manually changed to the same value as the collimation, the console viewer will not allow creation of MPR images due to the scan series being broken into serval series of images.
- Scan length changes with a change in field of view (FOV).
- Scan length changes on subsequent axial results.
- Surview scan lengths near 184.4mm & 135.0mm may result in unexpected scan start positions.
- There may be a discrepancy between the calculated reconstruction length and the actual scan length which may result in the inability to reconstruct the raw data. Offline reconstruction of the raw data is not possible. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction.
This action has been closed out on 08/11/2018 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |