| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00476-1 |
| Product Name/Description |
Ingenuity Core using software version 3.5.4
(Computed tomography (CT) x-ray diagnostic system)
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Philips received reports from the field that certain Ingenuity Core systems running software version 3.5.4 exhibited intermittent swirl-like ring artefacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images. A patient rescan may be required due to impairment of the diagnostic quality of the reconstructed images. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
There are no proactive actions for the user. Clinical judgment should be used by the clinician to determine if the images contained in the dataset without artefacts contain enough information to make a diagnosis. If these images are sufficient, no further action is required. If the images are not sufficient, a rescan of the patient may be required. Philips Healthcare is implementing software update version 3.5.5 to correct the above-described issue.This action has been closed-out on 30/01/2017. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |