| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00423-1 |
| Product Name/Description |
Brilliance CT 64, Ingenuity Core, Ingenuity Core 128 systems using software versions 2.6.1 or 3.5.4 (Computed tomography full-body x-ray system)
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Philips Healthcare received reports that certain Brilliance CT 64 Ingenuity Core systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare is advising that clinical judgment should be used by the customer/user to determine if the images contained in the dataset without artifacts contain enough information to make a diagnosis. If these images are sufficient, no further action is required. If the images are not sufficient, a re-scan of the patient is required. Philips Healthcare is implementing software update versions 2.6.2 or 3.5.5 to permanently correct the issue. This action has been closed-out on 12/02/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |