FDA Device recall Z-0446-2024
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541
- FDA Device
- Class II
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class II recall of ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541 by Elekta, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0446-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-25 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Elekta |
| Distribution | n/a |
Product
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; 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.
Identifiers
| code_info | UDI/DI 05060191071512, Serial Numbers: 153451, 154067, 154072, 153600, 153693, 152596, 152649, 152834, 152956, 152957,…UDI/DI 05060191071512, Serial Numbers: 153451, 154067, 154072, 153600, 153693, 152596, 152649, 152834, 152956, 152957, 153005, 153054, 153377, 153593, 153602, 153617, 153852, 154048, 154049, 154060, 152971, 152597, 151995, 153685, 154560, 153748, 153979, 153989, 152902, 153670, 152937, 153198, 151839, 151942, 151958, 151959, 151961, 152019, 152103, 152115, 152158, 152207, 152210, 152211, 152223, 152257, 152303, 152364, 152371, 152504, 152520, 152585, 152593, 152604, 152652, 152659, 152715, 152732, 152801, 152802, 152817, 152818, 152828, 152833, 152916, 152927, 152946, 152963, 152970, 152993, 153035, 153046, 153071, 153138, 153141, 153143, 153164, 153200, 153230, 153375, 153450, 153474, 153529, 153534, 153542, 153558, 153727, 153746, 153753, 153761, 153794, 153803, 153824, 153826, 153840, 153871, 153915, 153939, 154051, 154093, 154132, 154135, 154169, 154175, 154204, 154206, 154224, 154242, 154244, 154264, 154312, 154378, 154380, 154422, 154429, 154453, 154536, 154558; UDI/DI 050601 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0446-2024%22
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