| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00084-1 |
| Product Name/Description |
Philips Incisive CT system
Software version: 5.0
Reference numbers: 728143, 728144, 728149, 728146, 728148 & 728151
ARTG 229637
(Philips Electronics Australia Ltd - X-ray system, diagnostic, computed tomography, full-body)
ARTG 352131
(Philips Electronics Australia Ltd - X-ray system, diagnostic, computed tomography, full-body) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/02/2023 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified multiple software issues affecting Incisive CT systems which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels or the need for a CT rescan.
Issues identified that may occur include:
1. Artifacts in the images on perfusion images.
2. Orientation label reversed in 2D images.
3. Auto voice issues.
4. Not all images are reconstructed, or no image is displayed on the console monitor after enabling CCT single scan.
5. Ring artifact appears when soft tissue view is selected.
6. Error 0503 (HG000A00503) occurs during scanning process.
7. Calcium scoring study split into separate series after loading to ISP.
Philips has not received any reports of adverse events associated with these issues as of December 2022. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips advise that users may continue to use your system(s) in accordance with the intended use. Appendix A in the customer letter provides specific details regarding the issue descriptions and advice on actions to be taken.
A Philips Field Service Engineer will contact customers to schedule the installation of the software upgrade (FCO72800790) to resolve the issues.
This action has been closed out on 26/06/2024 |
| Contact Information |
1800 251 400 - Philips Service Delivery Team. |