| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01027-1 |
| Product Name/Description |
Siemens AX System (Digital fluoroscopicc x-ray system) fitted with MAVIG PORTEGRA 2 System (Radiation protection system)
Part Numbers for the MAVIG PORTEGRA 2 System: 7721165, 4787714, 7559375, 10281150, 10281151, 10281152 and 10281153 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems. The component would hold a pin in position in case that pin gets released and thus prevent system parts from becoming loose, leading to an adverse effect on the function and possibly becoming detached from the system. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users that a technician will perform an update to the affected systems. |
| Contact Information |
1800 310 300 - Siemens Regulatory Affairs |