Recall Z-0446-2024 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
| Date | Dec 1, 2023 (initiated Oct 25, 2023) |
| Status | Open, Classified |
| Reason | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension. |
| Root cause | Under Investigation by firm |
| Action | Elekta released Field Safety Notice to its consignees on the 10/25/2023 via email. The notice explained the issue, potential risk, and provides information for the safe use of the instrument until Elekta Field Service Representatives can perform the correction. |
| Quantity | 291 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Elekta Limited, Jun 11, 2021 |