| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00370-1 |
| Product Name/Description |
Brilliance Big Bore Oncology CT and Radiology CT (with software version 4.2.0)
(4D CT pulmonary phase issue)
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
An issue has been identified where a retrospective respiratory gated 4D CT scan is performed with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%). This may lead to a couple of scenarios that may result in misrepresentation of the 4D CT images with a respiratory gated 4D CT scan and reconstruction. In the event this occurs a misrepresentation of CT images may result, due to the incorrect image pulmonary phase annotation or the need to rescan the patient due to an incorrect image pulmonary phase. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is recommending users to follow the instructions as outlined in the recall notification letter. The letter contains information to prevent the occurrence of the scenarios as well as the corrective actions to take when they do occur.
This action has been closed out on 24/10/2018 |
| Contact Information |
1800 251 400 - Philips Cusotmer Care Centre |