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

Hazard

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.

Details from the source

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: worldwide Quantity: 1019 units Lot/code info: 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, 152724, 151366, 152047, 152074, 152075, 152133, 152197, 152290, 152291, 152395, 152462, 152465, 152646, 152682, 152945, 153476, 153620, 153640, 154071, 151815, 152157, 152602, 152726, 152729, 152750, 152763, 152806, 152987, 151771, 151905, 154255, 152482, 152580, 152582, 152583, 152586, 152639, 152735, 152738, 152785, 152797, 152850, 153124, 153290, 152119, 152603, 152942, 152744, 153122, 152452, 151972, 152016, 152038, 152052, 152251, 152267, 152287, 152523, 152572, 152578, 152605, 152606, 152611, 152826, 152880, 15292

UPC codes

05060191071505, 05060191071550

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.