| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00417-1 |
| Product Name/Description |
Philips Ingenuity Core128 with Software Version 3.5.5 (whole body Computed Tomograph (CT) x-ray system)
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
An issue has been found with the Ingenuity Core128 system with software version 3.5.5. If additional acquisitions/scans are requested prior to completion of the current reconstructions, not all planned images from the current reconstruction are displayed to the user. Users may not be aware the information is not lost, as the raw data can be reconstructed off-line displaying all requested reconstructions. If a rescan is required, there is potential for unnecessary radiation. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is requesting customers to verify that all planned image reconstructions are completed and to perform off-line reconstructions, if expected images are missing. Philips will be installing a software update to correct the issue. This action has been closed-out on 01/02/2016. |
| Contact Information |
1800 251 400 - Phillips Customer Care Centre |