• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Stereotactic Circular Collimator 3D Line stereotatic Hardware Accessoriessee related information
Date Initiated by FirmJuly 23, 2013
Date PostedNovember 04, 2013
Recall Status1 Terminated 3 on November 18, 2014
Recall NumberZ-0138-2014
Recall Event ID 65782
510(K)NumberK011255 
Product Classification Neurological stereotaxic Instrument - Product Code HAW
ProductStereotactic 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 ContactLinda Wetsel
770-300-9725
Manufacturer Reason
for Recall
Potential for clinical errors.
FDA Determined
Cause 2
No Marketing Application
ActionElekta 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 Commerce89
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
-
-