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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 182 07 13 001
Date submitted: 11/5/2013
Manufacturer:Elekta Limited
Device Type:Stereotactic Circular Collimator
Description: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.
Medical Device Identifier: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 )
Reason of Field Safety Corrective Action:With the current design, it is necessary for the stereotactic practitioner to implement processes and protocols, to manage the clinical application of these devices, and to be fully trained and current on the complete process of stereotactic radiosurgery. The likely contributing factors to errors in the clinical workflow which fall under this management are:
• The installation of an incorrect cone.

• The use of a consolidated field with an incorrect cone.

• For a manually input prescription, an incorrect diaphragm setting in MOSAIQ.

• An incorrect diaphragm setting in the Treatment Planning System .

• An incorrect diaphragm setting in Standard Therapy A failure to manage these conditions can cause clinical mistreatment.
Remedy Action:The solution is to upgrade current system, release of Important Field Safety Modification 200 02 408 023. The kits include:
1) Standard Therapy Removal Utility (STRU) – this permanently removes access to Standard Therapy on the host machine to make sure a Record and Verify (R&V) system log is always available in the Treatment Control System configuration.

2) Unique bar codes – which are printed on approved label material and applied to each collimator.

3) Bar Code Scanner – this is used in the treatment room to do a scan of the collimator.

4) An Important User Notice (IUN) - which gives the new workflow and user instructions.
Athorized Representative/Importer/Distributor:Analysis Device For Medical and Scientific Service ( ADMSS ), Dammam, (013) 8174422
Report Source:NCMDR
Source Ref. Number:140A798FA51CB
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments