| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00038-1 |
| Product Name/Description |
Brilliance CT series (6, 10, 16, 16 Power, 40, 64, CT Big Bore and CT Big Bore Oncology), iCT, iCT SP, Ingenuity Core, Ingenuity CT and
MX8000 Dual v. EXP (Computed tomography diagnostic x-ray systems)
Multiple serial numbers affected
ARTG: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
Philips Healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. Philips has determined the cause was a malfunction of the vertical brake of the patient support due to embrittlement of the vertical brake’s screws. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
If the couch moves down unexpectedly, please discontinue use of the device and contact your local Philips Field Service Engineer. A Philips Field Service Engineer will perform a brake repair or replacement on the affected systems to resolve the issue. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |