Recall archive / FDA device enforcement

ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System... — FDA record Z-0442-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 25, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; 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.
Classification: Class II
Recalling firm: Elekta, Inc.
Quantity: 315 units
Agency-reported status: Ongoing
Source record identifier: Z-0442-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	UDI/DI none, Serial Numbers: 152320, 105566, 152018, 152077, 152078, 152142, 152196, 152326, 152327, 152328, 152434, 152493, 152552, 152640, 152680, 152922, 152940, 152943, 153244, 153366, 153528, 153549, 153609, 153806, 154332, 154365, 151606, 151642, 151648, 151650, 151721, 151726, 151742, 151776, 151777, 151806, 151817, 151856, 151877, 151926, 151929, 151944, 151947, 152096, 152139, 152149, 152150, 152153, 152225, 152265, 152269, 152274, 152279, 152289, 152292, 152317, 152332, 152333, 152335, 152348, 152383, 152407, 152410, 152413, 152444, 152466, 152470, 152471, 152476, 152485, 152488, 152489, 152496, 152508, 152517, 152527, 152534, 152555, 152566, 152587, 152590, 152608, 152621, 152641, 152661, 152670, 152684, 152686, 152688, 152690, 152699, 152722, 152748, 152751, 152761, 152766, 152771, 152781, 152786, 152788, 152789, 152790, 152808, 152821, 152832, 152845, 152859, 152863, 152865, 152866, 152870, 152909, 152918, 152934, 152961, 153009, 153013, 153020, 153040, 153041, 153064, 153067, 153069, 153070, 153129, 153134, 153145, 153150, 153154, 153155, 153157, 153159, 153165, 153167, 153213, 153214, 153216, 153231, 153242, 153254, 153260, 153262, 153274, 153304, 153306, 153311, 153318, 153322, 153328, 153329, 153338, 153351, 153353, 153368, 153374, 153443, 153457, 153460, 153462, 153488, 153490, 153494, 153538, 153545, 153547, 153561, 153569, 153571, 153576, 153581, 153583, 153599, 153603, 153618, 153622, 153627, 153650, 153654, 153680, 153682, 153686, 153695, 153709, 153721, 153730, 153731, 153732, 153771, 153773, 153779, 153783, 153790, 153795, 153805, 153881, 153904, 153909, 153910, 153918, 153921, 153927, 153931, 153934, 153945, 153956, 153967, 153971, 153993, 153994, 154033, 154035, 154047, 154061, 154062, 154074, 154081, 154092, 154094, 154096, 154114, 154118, 154246, 154249, 154313, 154329, 154341, 154376, 154459, 154465, 154474, 154517, 151732, 152675, 151012, 105940, 151204, 151409, 151559, 151878, 152169, 152423, 152424, 151131, 151283, 152706, 151475, 152113, 152644, 153080, 153170, 153183, 153184, 153289, 154480, 153226, 153540, 153962, 154154, 151271, 152055, 152065, 152121, 152134, 152218, 152219, 151464, 105306, 151761, 152029, 105715, 152144, 153403, 151807, 151741, 152674, 152677, 153690, 151715, 151716, 151520, 153544, 151901, 152037, 152187, 152571, 152799, 154439, 154440, 153633, 152013, 151126, 105640, 151534, 152967, 152968, 153461, 153521, 153864, 154034, 105490, 152473, 151095, 152556, 151374, 151456, 151457, 151980, 152198, 152278, 153193, 153206, 153582, 154186, 154278, 151549

Label field

Details supplied by the agency

Lot, code or applicability

UDI/DI none, Serial Numbers: 152320, 105566, 152018, 152077, 152078, 152142, 152196, 152326, 152327, 152328, 152434, 152493, 152552, 152640, 152680, 152922, 152940, 152943, 153244, 153366, 153528, 153549, 153609, 153806, 154332, 154365, 151606, 151642, 151648, 151650, 151721, 151726, 151742, 151776, 151777, 151806, 151817, 151856, 151877, 151926, 151929, 151944, 151947, 152096, 152139, 152149, 152150, 152153, 152225, 152265, 152269, 152274, 152279, 152289, 152292, 152317, 152332, 152333, 152335, 152348, 152383, 152407, 152410, 152413, 152444, 152466, 152470, 152471, 152476, 152485, 152488, 152489, 152496, 152508, 152517, 152527, 152534, 152555, 152566, 152587, 152590, 152608, 152621, 152641, 152661, 152670, 152684, 152686, 152688, 152690, 152699, 152722, 152748, 152751, 152761, 152766, 152771, 152781, 152786, 152788, 152789, 152790, 152808, 152821, 152832, 152845, 152859, 152863, 152865, 152866, 152870, 152909, 152918, 152934, 152961, 153009, 153013, 153020, 153040, 153041, 153064, 153067, 153069, 153070, 153129, 153134, 153145, 153150, 153154, 153155, 153157, 153159, 153165, 153167, 153213, 153214, 153216, 153231, 153242, 153254, 153260, 153262, 153274, 153304, 153306, 153311, 153318, 153322, 153328, 153329, 153338, 153351, 153353, 153368, 153374, 153443, 153457, 153460, 153462, 153488, 153490, 153494, 153538, 153545, 153547, 153561, 153569, 153571, 153576, 153581, 153583, 153599, 153603, 153618, 153622, 153627, 153650, 153654, 153680, 153682, 153686, 153695, 153709, 153721, 153730, 153731, 153732, 153771, 153773, 153779, 153783, 153790, 153795, 153805, 153881, 153904, 153909, 153910, 153918, 153921, 153927, 153931, 153934, 153945, 153956, 153967, 153971, 153993, 153994, 154033, 154035, 154047, 154061, 154062, 154074, 154081, 154092, 154094, 154096, 154114, 154118, 154246, 154249, 154313, 154329, 154341, 154376, 154459, 154465, 154474, 154517, 151732, 152675, 151012, 105940, 151204, 151409, 151559, 151878, 152169, 152423, 152424, 151131, 151283, 152706, 151475, 152113, 152644, 153080, 153170, 153183, 153184, 153289, 154480, 153226, 153540, 153962, 154154, 151271, 152055, 152065, 152121, 152134, 152218, 152219, 151464, 105306, 151761, 152029, 105715, 152144, 153403, 151807, 151741, 152674, 152677, 153690, 151715, 151716, 151520, 153544, 151901, 152037, 152187, 152571, 152799, 154439, 154440, 153633, 152013, 151126, 105640, 151534, 152967, 152968, 153461, 153521, 153864, 154034, 105490, 152473, 151095, 152556, 151374, 151456, 151457, 151980, 152198, 152278, 153193, 153206, 153582, 154186, 154278, 151549

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

worldwide

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date: Dec 13, 2023
Recall initiation date: Oct 25, 2023
Center classification date: Dec 1, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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