ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Class I - Dangerous

🏥 Medical Devices Recalled: October 25, 2023 Elekta Other Medical Devices

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Elekta, Inc.
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Product Codes/Lot Numbers:

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