Z-0443-2024Class II

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System...

Name: Z-0443-2024 ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System...
Creator: Elekta, Inc.
Published: 2023-10-25
License: https://open.fda.gov/license/

Elekta Limited / initiated 2023-10-25 / Open, Classified

FDA source

Elekta, Inc. began a recall of ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear on 2023-10-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0443-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-25
Posted: 2023-12-01
Recalling firm: Elekta Limited
Product: ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Product code: IYE Accelerator, Linear, Medical
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 root cause: Under Investigation by firm
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.
Quantity in commerce: 1019 units
Distribution: worldwide
Product codes and lots: 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, 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152123, 152214, 152232, 152331, 152475, 152530, 152559, 152703, 152767, 152815, 153045, 153086, 153867, 154515; UDI/DI: 05060191071550, Serial Numbers: 152008, 153854, 153863, 153954, 153995, 109002, 152007, 152369, 152379, 152619, 152695, 152696, 152896, 152897, 152905, 152926, 153007, 153012, 153014, 153024, 153152, 153276, 153033, 153220, 151836, 153449, 154138, 151868, 152188, 152533, 152093, 152363, 152472, 154042, 152005, 152056, 152259, 152272, 152354, 152500, 152689, 152796, 153022, 153943, 154263, 154384, 153728, 151928, 152124, 152166, 152242, 152244, 152651, 151673, 153038, 151403, 151624, 151663, 151948, 151970, 151979, 152010, 152020, 152024, 152090, 152095, 152145, 152178, 152203, 152253, 152268, 152296, 152334, 152385, 152408, 152411, 152415, 152449, 152453, 152474, 152487, 152516, 152529, 152532, 152560, 152568, 152588, 152594, 152610, 152666, 152671, 152685, 152693, 152704, 152773, 152774, 152775, 152776, 152780, 152810, 152814, 152820, 152823, 152837, 152856, 152857, 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0443-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0442-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0443-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0444-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0445-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0446-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0447-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01

Product code IYE

K210500Class IIElekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited / cleared 2021-06-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)