Stereotactic Circular Collimator Product Usage: This device is intended to hold a patient's head in a fixed position and to localize and center the output of a linear accelerator (UNAC) to allow radiotherapy of brain tumors and other types of cerebral lesions.
This recall has been terminated (originally issued November 30, 2011).
- Company
- Elekta, Inc.
- Recall Initiated
- March 25, 2011
- Posted
- November 30, 2011
- Terminated
- October 2, 2012
- Recall Number
- Z-0319-2012
- Quantity
- 89 devices
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Recent newspaper articles outlined improper use of SRS Cone Collimator accessories that injured patients on Brainlab and Varian systems.
Distribution
Nationwide Distribution (USA) - including the states of: AZ, CA, FL, GA, MO, NJ, NM, NC, OR, TN, and WV
Lot / Code Info
848, 849, 850, 851, 852, 853, 1032, 1033, 1034, 928, 929, 930, 931, 932, 801, 802, 803, 804, 805, 980, 981, 982, 983, 984, 889, 890, 891, 892, 893, 894, 908, 909, 910, 911, 912, 833, 834, 835, 836, 837, 843, 844, 845, 846, 847, 1017, 1018, 1019, 1020, 1021, 903, 904, 905, 906, 907, 883, 884, 885, 886, 933, 935, 936, 937, 940, 974, 975, 976, 977, 978, 941, 942, 943, 944, 945, 946, 947, 948, 949, 950, 1012, 1013, 1014, 1015, 1016, 1027, 1028, 1029, 1030, 1031
Root Cause
Under Investigation by firm
Action Taken
Elekta sent an IMPORTANT NOTICE letter dated March 25, 2011 to all affected customers. The letter identified the affected product, the problem, key safety procedures and information to users for safe operation of the Stereotactic Circular Collimator. Elekta will issue a Mandatory Action Field Change Order which will include an updated Circular Collimator Instructions for Use - 102022201 and new labels. The notice instructs Users to file this document in the Important Notice section of the appropriate User Manual. Also, Elekta is offering some free WebEx sessions which will include the procedures and recommended operation of these types of accessories. Customers are instructed to register at www.elekta.com/SafeAccessories.