| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01070-1 |
| Product Name/Description |
Philips Brilliance iCT
CT Systems with software version 4.1.6
Brilliance iCT SP (728311)
Brilliance iCT (728306)
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Philips have identified the following issues with Brilliance iCT s/w V4.1.6
1. Scan Parameters Exceeds System resources
2. Scan may start at the top of the head, which may not be where the operator is expecting the scan to start
3. Error message appears “The exam application stopped working” & will instruct the operator to close the program
4. During a Bolus tracking procedure, after acquiring the surview, locator & tracker, the scanner may move into place, give patient breathing instructions, & then fail to acquire the scan
5. Image volumes are not found in patient directory when thin images are included in one of the multiple results
6. Application may fail when modifying the results Plan Box during 3D Calcium Score
7. Tube too hot
8. Memory overflow
9. While the reconstruction is in progress disconnecting the Recon box (CIRS) may not give error message
10. In the Plan viewer, if the start position is modified the total length of the acquisition will change as well. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare is notifying the affected users of these issues via this Customer Information Letter. The customers will be contacted by their local Field Service Engineer for implementation of the field correction under FC072800678 to be conducted free of charge to the customer.
This action has been closed out on the 16/10/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |