| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00255-1 |
| Product Name/Description |
Elekta PreciseTreatment Table (Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use)
Ranges: 124001 to 126924, 133801 to 133999, 213000 to 213189
ARTG Number: 165045 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
The Column Rotation can accidentally be moved to a different position while in the locked position. This can occur between fields and can cause clinical mistreatment. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Elekta has provided work around instructions to ensure the treatment table is in the correct position. If end users determine that it is possible to rotate the column with the brakes applied they must contact their service representative. Elekta is currently developing a correction to repair the problem. |
| Contact Information |
02 8907 1800 - Elekta Regulatory Affairs |