Z-0138-2014Class II

Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class...

Name: Z-0138-2014 Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class...
Creator: Elekta, Inc.
Published: 2013-07-23
License: https://open.fda.gov/license/

Elekta Limited / initiated 2013-07-23 / Terminated

FDA source

Elekta, Inc. began a recall of Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy... on 2013-07-23. FDA classified it as Class II and gives the reason as "Potential for clinical errors". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0138-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-23
Posted: 2013-11-04
Terminated: 2014-11-18
Recalling firm: Elekta Limited
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.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Potential for clinical errors.
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0138-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0138-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-04

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)