FDA Recall
Open, Classified
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Recall: Z-0445-2024
·
Initiated October 25, 2023
Recall
- Recall Number
- Z-0445-2024
- Event Number
- 93264
- Firm
- Elekta, Inc.
- FEI Number
- 1037831
- Product Code
- IYE
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- October 25, 2023
- Posted
- December 1, 2023
- Address
- 400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227
Description
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
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.
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.
Distribution
worldwide
Quantity
451 units