| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00111-1 |
| Product Name/Description |
Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos RHD, Luminos RF Classic, Luminos Fusion, Luminos Select (Fluoroscopic diagnostic x-ray systems)
ARTG Numbers: 102181 & 144246 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
There is potential for malfunction in cases where the table vertical tilt movement is obstructed by a solid object resulting in a collision. This can result in damage to the system mechanics that may not necessarily prevent the table from functioning immediately, but can lead to complete failure of the table mounting mechanics. In this case, the table may drop resulting in potentially hazardous situations for patients and/or staff. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising customers to avoid any collision of the table with objects in the table's operating area. Customers should contact their Siemens service representative for a precautionary inspection should such a collision occur or have occurred in the past. |
| Contact Information |
1800 310 300 - Siemens Regulatory Affairs |