| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00586-1 |
| Product Name/Description |
Brilliance iCT and iCT SP, with software versions v4.1.3 and v4.1.5
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 & therefore additional radiation doses. There have been no reports of injuries as a result of these issues;
- Scan length changes with a change in the field of view (FOV);
- The DoseRight algorithm calculates a water equivalent diameter that is larger than measured on a cylindrical phantom when an 80 kVp or 120 kVp surview is used. This will result in a mAs value for the scan that is higher than suggested when using a 100 kVp or 140 kVp surview. (Note: The reported mAs and CTDI values are correct for all scans & surviews);
- Wrong scan time estimation due to incorrect intergration time causes the SurView scan near 184mm &135mm may result in unexpected scan start positions; &
- There may be a discrepancy between the calculated reconstruction length & the actual scan length which may result in the inability to reconstruct the raw data. Offline reconstruction of the raw data is also not possible. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction.
This action has been closed out on the 12/10/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |