| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01314-1 |
| Product Name/Description |
Ingenuity TF PET/CT System with software version 4.0.3.26129
ARTG Number: 292543 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
17/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Philips is advising of an issue with the QC Baseline Test. During the PET Daily Quality Control (QC) Baseline Test, customers may see a popup message on the console stating “Communications Error. Do you wish to continue?”, with the options of “OK” or “Cancel”. Answering either way may cause the Daily QC to fail. In some cases, once this message appears, it will re-appear each time the Daily QC is run. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Where Daily QC is unable to be run due to a continual Communication Error, Philips is advising customers to contact their Philips Service Representative to resolve the issue. Philips will correct the issue in an upcoming software release.
This action has been closed out on 18/11/2020 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |