| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00813-1 |
| Product Name/Description |
Allura Xper FD10 F and Allura FD10/10 (diagnostic, fluoroscopic x-ray system)
Product Codes: 733001, 722002, 722003, 722005, 722010, 722011, 722014, 722019, 722123 & 722133
ARTG Number: 98560 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
While the C-arc Base rotation is moved manually and at the same time a motorised Base rotation is initiated followed by a movement stop request the geometry of the System will reset. Consequently the stand movements and table movements then will not be available for about 90 seconds. The table top will be free floating and can manually be moved in both longitudinal and transversal direction |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising users not to initiate a motorised movement of the base rotation when it is moved manually. The system sees this as a conflict and will perform a Geo reset. A software update will be available in Quarter 4 2013. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |