Z-0319-2012

Stereotactic Circular Collimator

Name: Z-0319-2012 Stereotactic Circular Collimator
Creator: Elekta, Inc.
Published: 2011-03-25
License: https://open.fda.gov/license/

Elekta Limited / initiated 2011-03-25 / Terminated

FDA source

Elekta, Inc. began a recall of Stereotactic 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... on 2011-03-25. The reason FDA records is "Recent newspaper articles outlined improper use of SRS Cone Collimator accessories that injured patients on Brainlab and Varian systems". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0319-2012
Status: Terminated
Initiated: 2011-03-25
Posted: 2011-11-30
Terminated: 2012-10-02
Recalling firm: Elekta Limited
Product: Stereotactic 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.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Recent newspaper articles outlined improper use of SRS Cone Collimator accessories that injured patients on Brainlab and Varian systems.
FDA root cause: Under Investigation by firm
Action: Elekta 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 commerce: 89 devices
Distribution: Nationwide Distribution (USA) - including the states of: AZ, CA, FL, GA, MO, NJ, NM, NC, OR, TN, and WV
Product codes and lots: 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

Product code HAW

K011255Class II3D Line Sterotactic Hardware Accessories3D Line USA, Inc. / cleared 2001-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)