| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00068-1 |
| Product Name/Description |
Brilliance iCT and Brilliance iCT SP with software versions 4.1.0.xxxxx, or 4.1.1.xxxxx, or 4.1.2.xxxxx
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified a software defect that may result in the scanner updating the planned scan length to be longer than the user intended. This may happen if:
1. The exam is planned with low pitch and rotation time values, for example, 0.3 pitch and 0.27 rotation time, and
2. The plan scan length is increased or lengthened on the Surview/Scout, and
3. The system displays a pop-up message that the current pitch, rotation time, and planned scan length are incompatible and suggests a new pitch and rotation time.
4. If the user accepts the suggested pitch and rotation time changes, the system adjusts the plan to the maximum allowed scan length, which will plan the study beyond the original intended length. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is providing instruction to assist identify if a system is affected and advising end users to ensure that the scan length is verified prior to initiating the scan. A Philips Field Service Engineer will contact affected customers to arrange for the software to be updated. This action has been closed-out on 19/07/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |