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U.S. Department of Health and Human Services

Class 2 Device Recall Stereotactic Circular Collimator

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 Class 2 Device Recall Stereotactic Circular Collimatorsee related information
Date Initiated by FirmMarch 25, 2011
Date PostedNovember 30, 2011
Recall Status1 Terminated 3 on October 02, 2012
Recall NumberZ-0319-2012
Recall Event ID 60150
510(K)NumberK011255 
Product Classification Neurological stereotaxic instrument - Product Code HAW
ProductStereotactic 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.
Code Information 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
Recalling Firm/
Manufacturer		 Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross GA 30092-3011
For Additional Information ContactThomas Valentine
770-670-2548
Manufacturer Reason
for Recall		Recent newspaper articles outlined improper use of SRS Cone Collimator accessories that injured patients on Brainlab and Varian systems.
FDA Determined
Cause 2		Under Investigation by firm
ActionElekta 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.
Quantity in Commerce89 devices
DistributionNationwide Distribution (USA) - including the states of: AZ, CA, FL, GA, MO, NJ, NM, NC, OR, TN, and WV
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HAW
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