| Class 2 Device Recall Stereotactic Circular Collimator 3D Line stereotatic Hardware Accessories |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = HAW
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