| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00983-1 |
| Product Name/Description |
Brilliance CT 6, 16, MX8000 v. EXP and GEMINI Dual Oil Accumulator within the Gantry (combination diagnostic imaging system (PET/CT)
Multiple serial numbers affected
ARTG Numbers: 98868 and 118077 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
No action needs to be taken at this point by the customer or user. Philips Field Service Engineer will schedule a time to inspect and repair all the affected systems. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |