| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00212-1 |
| Product Name/Description |
Brilliance CT 64-channel with Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, Ingenuity Elite and Ingenuity CT
Software release versions between 4.0.0 and 4.1.2 inclusive
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
It is possible for the system to invert the sign (positive/negative) of the longitudinal position value displayed on an axial scan image.
The following key events must take place for harm to occur:
- The patient is placed in a “feet-first” orientation.
- An interventional CT procedure is scheduled.
- Contrary to typical clinical practice, a Multi-Planar Reconstruction (MPR) is used for planning the interventional procedure (this issue only occurs in images produced using MPR).
- A check scan is not performed (normal clinical practice indicates the use of a check scan before beginning an interventional procedure).-
- The needle tip placement is not confirmed as directed (this practice would prevent more than a minimal ingress of an intervention at an undesired location). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising their customers to refrain from using Multi Planar Reconstruction (MPR) derived images for identifying the absolute position of the intervention for feet-first patient orientation. A software update will be implemented to correct the issue. This action has been closed-out on 4/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |