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

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.

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.