| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00987-1 |
| Product Name/Description |
Philips Brilliance 16-Slice (Air), Brilliance 64 CT, Ingenuity Core, Ingenuity Core 128, Brilliance CT Big Bore, Ingenuity Flex. Software versions V3.6.1, V3.6.2, V3.6.4, and V3.6.5
(X-ray system, diagnostic, computed tomography, full-body)
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
Image Position Accuracy - Image Rotation Calibration program performed by field service engineer can report pass but fail to produce the correct angular rotation offset value for the ultra-fast scan mode. The inaccurate angular rotation offset can impact the accuracy of radiation treatment planning.
Tracker Image Artefact - Tracker scan image of CT Angiography (CTA) examination can exhibit a streaking artefact. Due to the streaking artefact, the automatic clinical scan may be triggered at the wrong time resulting in suboptimal CT diagnostic images that do not capture the bolus peak of the imaged body section.
Ring/dot image Artefact due to X-ray Measurement - After a complete system power shutdown and power up, if a head scan is performed without air calibration and without quick IQ check scan after power up, intermittent ring/dot image artifacts in the reconstructed images may occur. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare are providing users with work around instructions to follow as an interim measure. A software update will be installed on all affected systems as a permanent correction. This action has been closed-out on 31/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |