| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01103-1 |
| Product Name/Description |
Extended Brilliance Workstation with running software versions 4.0.2, V4.5.2 or V4.5.3 (To perform offline measurement and manipulation of CT images, diagnostic X-ray system)
ARTG Number: 119929 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
30/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
1. When translating the Calcium Scoring (CS) results into Chinese, the percentile is not reported accurately.
2. In the Calcium Scoring protocol, the protocol is switched to Mass Score but the protocol name remains Agatston.
3. Spline measurement values do not update when adding control point (CP) and when changing the length of the line.
4. In the CT Viewer (CTV) PET studies being loaded from remote with Slope different than 1, appear incorrectly in 2D scene and are not displayed with the correct CUV values.
5. Loading PET images in the CT Viewer (CTV) / Quick Review from remote with Slope different than 1, the images with the different Slope appear incorrectly with wrong SUV values in Perception and in QR. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is providing work around instructions for each issue and will be implementing a software update to correct the problem. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |