ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiatio...
FDA Device Recall #Z-0444-2024 — Class II — October 25, 2023
Recall Summary
| Recall Number | Z-0444-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 25, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Elekta, Inc. |
| Location | Atlanta, GA |
| Product Type | Devices |
| Quantity | 264 units |
Product Description
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
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.
Distribution Pattern
worldwide
Lot / Code Information
UDI/DI 05060191071536, Serial Numbers: 152110, 153550, 153363, 152650, 151851, 153300, 152721, 152816, 152539, 153879, 154099, 154121, 154230, 154581, 151909, 152186, 152314, 152542, 152728, 152643, 151984, 153334, 152057, 152086, 152107, 152129, 152907, 153327, 153820, 153844, 153084, 151712, 151713, 153522, 151873, 152501, 153675, 151834, 151923, 151924, 151925, 152076, 154100, 151725, 151804, 151825, 151826, 152337, 152338, 152339, 152662, 152936, 153629, 153632, 153676, 153678, 152397, 153636; UDI/DI 05060191071567, Serial Numbers: 152718, 153868, 153870, 153877, 153948, 154180, 152778, 151562, 151563, 151991, 151992, 151993, 152213, 152450, 152456, 152531, 152642, 152663, 152782, 152791, 152829, 152862, 152962, 153125, 153270, 153343, 153759, 153789, 153886, 154145, 154147, 154247, 154330, 154499, 153925, 154201, 152171, 152280, 151750, 152221, 152255, 152509, 152558, 152612, 152831, 153066, 153135, 153229, 153246, 153704, 153772, 154191, 154428, 154510, 152146, 152355, 151994, 152001, 153098, 152436, 152935, 153414, 153811, 154270, 154471, 154472, 154136, 151858, 152209, 152384, 152497, 152498, 153111, 153156, 153362, 153446, 153718, 154058, 152486, 153234, 153747, 151772, 151840, 151949, 152170, 152312, 152368, 152480, 152672, 152687, 152739, 152753, 152899, 152904, 152913, 152919, 152952, 152977, 153060, 153168, 153284, 153297, 153325, 153349, 153551, 153553, 153605, 153660, 153770, 153813, 153888, 153920, 153955, 154006, 154228, 154238, 154240, 154446, 109008, 151731, 152702, 152869, 154029, 154102, 151453, 152840, 152841, 153388, 153389, 153440, 153683, 152873, 152958, 153423, 151872, 153266, 153505, 153714, 151880, 152341, 152342, 153326, 153205, 153977, 153178, 152319, 154010, 152306, 153737, 153760, 152191, 152638, 153059, 154235, 154309, 151964, 153119, 154041, 152367, 153972, 153981, 153983, 153992, 152184, 152708, 152231, 153809, 151863, 152270, 152794, 152982, 153516, 153885, 154253, 154295, 154318, 154357, 151665, 152058, 152059, 152404, 152723, 152598, 154463, 152120, 152143, 153089, 153092, 153579, 153850, 154122, 152479, 152858, 152878, 151849, 152155, 152205, 152483, 152377, 152378, 152380, 152381, 153137, 154037, 154563, 153688,
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| Z-1164-2026 | Class II | Brand Name: Elekta Medical Linear Accelerator ... | Dec 14, 2025 |
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| Z-1078-2026 | Class II | MOSAIQ Oncology Information System with Particl... | Dec 10, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.