—#120136

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.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K011255
Affected lot / code info: 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

Why it was recalled

Potential for clinical errors.

Root cause (FDA determination)

No Marketing Application

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter Ne, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: Nationwide distribution: USA including the states of AZ, CA, FL, GA, MO, NJ, NM, NC, OR, TN and WV.

Timeline

Recall initiated: 2013-07-23
Posted by FDA: 2013-11-04
Terminated: 2014-11-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #120136. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.