Recall Z-0445-2024
Elekta, Inc. · initiated October 25, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Codes / lots: UDI/DI 05060191071529, Serial Numbers: 153396, 153671, 109003, 153383, 153384, 153055, 153980, 154001, 154002, 154003, 154004, 154272, 153104, 153188, 153243, 153745, 153836, 153872, 153876, 154123, 154148, 154199, 154250, 154260, 154267, 154269, 154449, 154498, 154550, 152951, 153140, 153525, 153526, 153532, 154218, 153621, 153951, 153949, 154028, 154548, 154239, 154262, 153413, 153829, 154163, 154101, 152777, 153037, 153142, 153144, 153177, 153186, 153187, 153189, 153277, 153364, 153399, 153425, 153426, 153471, 153510, 153537, 153578, 153625, 153661, 153752, 153762, 153782, 153797, 153808, 153816, 153847, 153858, 153950, 153986, 153997, 154046, 154070, 154084, 154085, 154127, 154178, 154202, 154217, 154280, 154372, 154374, 154381; UDI/DI 05060191071574, Serial Numbers: 153722, 109005, 109007, 153003, 153008, 153314, 153337, 153427, 153428, 153482, 153649, 153900, 154023, 154024, 154050, 154087, 154299, 154300, 153248, 153699, 154043, 154395, 154435, 154179, 154131, 153658, 153830, 154221, 154473, 153976, 153128, 153608, 154505, 154531, 154325, 153406, 153601, 153607, 153667, 153720, 153723, 153751, 153839, 153862, 153940, 153985, 154055, 154076, 154140, 154149, 154283, 154293…
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.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-0445-2024
- Initiated
- October 25, 2023
- Posted by FDA
- December 1, 2023
- Product code
- IYE – Accelerator, Linear, Medical
- Quantity
- 451 units
- Distribution
- worldwide
- Recalling firm
- Elekta, Inc., Atlanta, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0442-2024 Class II | ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical…Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a… | 10/25/2023Open, Classified |
| Z-0443-2024 Class II | ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle…Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a… | 10/25/2023Open, Classified |
| Z-0444-2024 Class II | ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle…Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a… | 10/25/2023Open, Classified |
| Z-0446-2024 Class II | ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical…Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a… | 10/25/2023Open, Classified |
| Z-0447-2024 Class II | ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy…Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a… | 10/25/2023Open, Classified |