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U.S. Department of Health and Human Services

Class 2 Device Recall Stereotactic Circular Collimator 3D Line stereotatic Hardware Accessories

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  Class 2 Device Recall Stereotactic Circular Collimator 3D Line stereotatic Hardware Accessories see related information
Date Initiated by Firm July 23, 2013
Date Posted November 04, 2013
Recall Status1 Terminated 3 on November 18, 2014
Recall Number Z-0138-2014
Recall Event ID 65782
510(K)Number K011255  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories

The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.
Code Information 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
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Linda Wetsel
770-300-9725
Manufacturer Reason
for Recall		 Potential for clinical errors.
FDA Determined
Cause 2		 No Marketing Application
Action Elekta sent an Important Field Safety Notice dated 7/2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised of the issue and recommendation to resolve either by upgrading their system or to discontinue a clinical use of the device. For further questions please call ( 770 ) 300-9725.
Quantity in Commerce 89
Distribution Nationwide distribution: USA including the states of AZ, CA, FL, GA, MO, NJ, NM, NC, OR, TN and WV.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HAW and Original Applicant = 3D LINE USA, INC.
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