Elekta SL Series/Precise Digital Accelerator. The product is used with radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
This recall has been terminated (originally issued March 18, 2010).
- Company
- Elekta, Inc.
- Recall Initiated
- October 1, 2005
- Posted
- March 18, 2010
- Terminated
- March 25, 2010
- Recall Number
- Z-1159-2010
- Quantity
- 315 units
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Customer reported larger than expected variations in wedge factory with gantry rotation.
Distribution
United States, Canada and Mexico.
Lot / Code Info
Model SL15, Serial Nos. 105102, 105333, 105481, 105279, 1054424, 105325, 105364, 105387, 105291, 105280, 105261, 105297, 105355, 105386, 105342, 105367; Model SL18, Serial Nos. 105213, 105392, 105395, 105326, 105203, 105369, 105284, 105153, 105166, 105324, 105265, 105320, 105177, 105305, 105122, 105199, 105359, 105366, 105126, 105363, 105178, 105233; Model SL25, Serial Nos. 105013, 105204, 105245, 105373, 105376, 105275, 105277, 105127, 105196, 105393, 105186, 105217, 105210, 105117, 105137, 105215105194, 105195, 105228, 105236, 105235, 105104, 105240, 105368; Model PRECISE ACC, Serial Nos. 105992, 105894, 105563, 105806, 105902, 105627, 105706, 105785, 105821, 105871, 105648, 105655, 105882, 105960, 105754, 105886, 105606, 105585, 105731, 105989, 105727, 105782, 151075, 151077, 151098, 105841, 151099, 105630, 151014, 105895, 105816, 105864, 105846, 1055559, 105657, 105853, 105854, 105829, 151016, 105660, 105844, 105890, 105621, 105587, 151035, 105580, 105809, 105644, 105593, 105705, 105699, 105803, 105723, 105647, 105898, 105369, 105949, 105868, 105998, 105637, 105837, 105636, 105716, 105717, 151029, 105759, 105770, 105772, 105776, 105925, 105568, 105650, 105591, 105929, 105584, 105624, 105941, 105666, 108573, 105926, 105646, 105676, 105260, 105773, 105936, 105872, 105678, 151159, 151030, 105910, 105969, 151015, 105812, 105796, 105950, 105881, 105859, 105728, 105561, 105590, 105612, 105567, 105744, 105566, 105879, 105828, 105856, 105918, 105555, 105610, 105883, 105914, 105990, 105586, 151154, 105649, 105565, 105564; Model SYNERGY PLAT, Serial Nos. 151033, 151216, 151173, 151053, 105826, 151200, 151201, 151116, 151025, 151160, 105982, 151256, 151076, 151110, 151008, 151093, 151229, 105932, 151143, 151038, 151059, 151260, 151130, 151024, 151214, 151167, 151051, 151176, 151080, 151104, 151259, 151238, 151084, 105984, 151155, 151156, 151157, 151074, 151266, 151134, 151141, 151055, 151073, 151178, 151168, 151151; Model SL20, Serial Nos. 105285, 105093, 105321, 105358, 105286, 105295, 105249, 105274, 105288, 105381, 105403, 105323, 105319, 105312, 105316, 105257, 105267, 105207, 105057, 105351, 105327, 105273, 105185, 105339, 105300, 105187, 105382, 105154; Model SL75/5, Serial Nos. 103137, 103172, 103174, 103092, 103091, 103130, 103131, 103124, 103394, 103099, 103159, 103081, 103384, 103026, 103053, 103050, 103110, 103001, 103177, 103161, 103030, 103084, 103064, 103055, 103154, 103399, 103346, 103375, 103027, 103386; Model SL1+, Serial Nos. 105447, 105465, 105518, 105528, 105514, 105478, 105466, 105519, 105498, 105453, 105492, 105467, 105445, 105452; Model SL1, Serial Nos. 105475, 105521, 105549, 105494, 105437, 105503, 105530, 105544, 105488, 105515, 105482, 105532; Model SL75/20, Serial Nos. 273, 266, 269, 274
Root Cause
Device Design
Action Taken
Important Notice A280 "Wedge Matching Procedure" (dated 11/18/05) was sent to all effected customers. The Important Notice described the issue, warnings and cautions and corrective instructions/Maintenance to take to eliminate occurrence. Direct questions to your local Elekta Limited representative.