ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Ac
FDA device recall Z-0442-2024 · posted 2023-12-01 · Open, Classified
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- IYE
- Quantity affected
- 315 units
- Distribution
- worldwide
- Date initiated
- 2023-10-25
- Date posted
- 2023-12-01
- Location
- Atlanta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD (K210500) | Elekta Limited | 2021-06-11 |