Elekta Limited

Sites affected will be those meeting ALL three criteria below: 1- Running Monaco Release 3.30 and higher 2- Using a CT Slice Spacing not equal to the CT Slice Thickness 3- Using the Image Statistics Tool to quantify CT phantom densities which are then used to populate the CT to ED file. ................. FDA update code : Focal Sim, Focal Release 4.80

Radiotherapy, planning and verification systems software

versions 1.40 – 2.50

Radiation Treatment Planning System Software

MRT 13521 ............................ FDA Update codes : ( 933, 935, 936, 937, 940, 843, 844, 845, 846, 847, 833, 834, 835, 836, 837, 801, 802, 803, 804, 805, 908, 909, 910, 911, 912, 889, 890, 891, 892, 893, 894, 848, 849, 850, 851, 852, 853, 974, 975, 976, 977, 978, 1032, 1033, 1034, 928, 929, 930, 931, 932, 980, 981, 982, 983, 984, 1017, 1018, 1019, 1020, 1021, 883, 884, 885, 886, 1012, 1013, 1014, 1015, 1016, 1027, 1028, 1029, 1030, 1031, 941, 942, 943, 944, 945, 946, 947, 948, 949, 950, 903, 904, 905, 906, 907 )

The Stereotactic Collimator is an add-on device used for the collimation of photon beams on a digital accelerator. The collimator focuses the photon beam inside a conical aperture of known dimensions. This additional collimation creates a very fine circular radiation beam.

All Desktop Pro™ R6.0.0, Desktop Pro™ R6.1.0, Desktop Pro™ R6.2.0 and Desktop Pro™ R7.0.0 systems

Treatment planning system

All HexaPOD evo RT Couchtops up to S/N 042277

Radiotherapy treatment patient positioning system