Recall Z-1159-2010 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Elekta SL Series/Precise Digital Accelerator. The product is used with radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
| Date | Mar 18, 2010 (initiated Oct 1, 2005) |
| Status | Terminated |
| Reason | Customer reported larger than expected variations in wedge factory with gantry rotation. |
| Root cause | Device Design |
| Action | Important Notice A280 "Wedge Matching Procedure" (dated 11/18/05) was sent to all effected customers. The Important Notice described the issue, warnings and cautions and corrective instructions/Maintenance to take to eliminate occurrence. Direct questions to your local Elekta Limited representative. |
| Quantity | 315 units |
| Distribution | United States, Canada and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032996 | ELEKTA SYNERGY SYSTEM Elekta Oncology Systems, Ltd., Oct 23, 2003 |