ELEKTA LIMITED Elekta Infinity recall
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Why was ELEKTA LIMITED Elekta Infinity recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 05060191071512, Serial Numbers: 153451, 154067, 154072, 153600, 153693, 152596, 152649, 152834, 152956, 152957, 153005, 153054, 153377, 153593, 153602, 153617, 153852, 154048, 154049, 154060, 152971, 152597, 151995, 153685, 154560, 153748, 153979, 153989, 152902, 153670, 152937, 153198, 151839, 151942, 151958, 151959, 151961, 152019, 152103, 152115, 152158, 152207, 152210, 152211, 152223, 152257, 152303, 152364, 152371, 152504, 152520, 152585, 152593, 152604, 152652, 152659, 152715, 152732, 152801, 152802, 152817, 152818, 152828, 152833, 152916, 152927, 152946, 152963, 152970, 152993, 153035, 153046, 153071, 153138, 153141, 153143, 153164, 153200, 153230, 153375, 153450, 153474, 153529, 153534, 153542, 153558, 153727, 153746, 153753, 153761, 153794, 153803, 153824, 153826, 153840, 153871, 153915, 153939, 154051, 154093, 154132, 154135, 154169, 154175, 154204, 154206, 154224, 154242, 154244, 154264, 154312, 154378, 154380, 154422, 154429, 154453, 154536, 154558; UDI/DI 05060191071543, Serial Numbers: 153741, 154363, 152506, 152768, 152969, 153004, 153047, 153048, 153120, 153121, 152478, 152772, 153303, 153402, 153626, 152668, 152669, 152692, 152853, 152979, 152984, 153015, 153017, 153053, 153308, 153802, 154065, 153946, 153960, 154082, 154130, 154144, 154189, 154229, 154289, 154290, 154302, 154311, 154414, 154423, 154475, 153472, 152888, 153298, 154277, 154297, 154310, 154355, 154434, 151044, 152554, 153076, 153237, 153324, 153586, 153961, 154211, 154403, 154231, 153441, 153236, 153511, 153646, 153652, 153655, 153674, 153677, 153845, 153869, 153982, 154134, 154159, 154208, 154209, 154213, 152996, 153010, 153052, 153285, 153288, 153294, 153792, 153799, 154115, 154467, 153350, 153866, 152370, 153878, 154366, 154582, 153933, 153001, 154181, 154205, 153531, 153631, 153692, 153743, 153987, 154045, 154468, 152709, 153615, 153103, 153332, 153907, 153091, 152031, 152163, 152175, 152192, 152200, 152222, 152388, 152392, 152432, 152469, 152481, 152491, 152502, 152556, 152599, 152601, 152618, 152673, 152784, 152792, 152798, 152955, 152959, 153019, 153021, 153032, 153036, 153050, 153061, 153068, 153114, 153136, 153253, 153282, 153319, 153321, 153342, 153354, 153429, 153442, 153448, 153464, 153491, 153493, 153535, 153536, 153548, 153597, 153598, 153681, 153719, 153738, 153749, 153798, 154069, 154117, 154182, 154319, 154387, 154485, 154504, 154512, 154535, 154565, 154265
- Product
- ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
- Recalling firm
- Elekta, Inc.
- Quantity
- 291 units
- Distribution
- worldwide
- Recall date
- December 13, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)