| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01187-1 |
| Product Name/Description |
Brilliance 64 system with software version 4.00xx516 and Ingenuity CT system running software version 4.00xx518 (full body CT systems)
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
1. During an interventional procedure with an interventional exam card reconstruction increment set to a negative value, one exposure of CCT was not reconstructed – there was radiation but images were not updated on the screen.
2. When moving the couch using the gantry buttons during an interventional procedure & the user chooses an interventional exam card with the reconstruction increment set to a negative value, the user has to wait a few seconds for the new position to update. There is an image update delay at about 5 second intervals.
3. When reconstructing images with O-MAR the system may fail to provide a non-OMAR set of images as required. The non-OMAR images must be manually reconstructed.
4. The rotor begins to spin without waiting for Service personnel to request the GO command.
5. Incorrect CBV values in the Brain Perfusion application may occur if the user takes brain perfusion images from a GE scanner into a specific application installed on a Philips scanner.
|
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is provided work around instructions for the issue and will be implementing a software update to correct the problem. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |