FDA Device recall Z-0443-2024
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511
- FDA Device
- Class II
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class II recall of ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511 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-0443-2024 |
| 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 Synergy, REF MRT 8501, MRT 8511; 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 05060191071505, Serial Numbers: 154549, 151917, 151963, 152072, 152081, 152131, 152382, 151838, 152318, 152807,…UDI/DI 05060191071505, Serial Numbers: 154549, 151917, 151963, 152072, 152081, 152131, 152382, 151838, 152318, 152807, 151951, 152416, 153147, 153148, 153963, 151821, 151845, 151940, 152160, 152162, 152164, 152389, 152393, 152394, 152634, 152635, 152636, 152664, 152665, 152725, 152992, 151850, 151920, 152082, 152089, 152111, 152546, 152548, 152299, 152403, 152503, 152676, 152950, 151857, 151690, 151744, 151745, 151766, 151831, 151859, 151900, 151950, 152046, 152137, 152194, 152202, 152216, 152258, 152276, 152376, 152390, 152391, 152399, 152414, 152430, 152431, 152513, 152521, 152557, 152576, 152645, 152647, 152712, 152719, 152740, 152743, 153093, 153115, 153126, 153258, 153299, 153475, 153554, 153804, 153911, 154415, 151852, 151894, 151971, 152185, 152241, 152297, 152422, 152429, 152584, 152616, 152628, 152631, 152681, 152698, 152746, 152747, 152770, 152804, 152811, 152812, 152813, 152985, 153256, 153286, 153546, 152014, 152208, 153952, 152883, 152714, 154342, 152724, 151366, 152047, 1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0443-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.