Z-0014-2012

Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy

Name: Z-0014-2012 Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy
Creator: Elekta, Inc.
Published: 2011-05-25
License: https://open.fda.gov/license/

Elekta Limited / initiated 2011-05-25 / Terminated / root cause: design

FDA source

Elekta, Inc. began a recall of Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy on 2011-05-25. The reason FDA records is "It is possible to load different patients in the record and verify (R&V) system and in the multilead control software (MCS)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0014-2012
Status: Terminated
Initiated: 2011-05-25
Posted: 2015-06-26
Terminated: 2014-01-14
Recalling firm: Elekta Limited
Product: Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: It is possible to load different patients in the record and verify (R&V) system and in the multilead control software (MCS).
Root cause tag: design
FDA root cause: Device Design
Action: Elekta, Inc. sent an "IMPORTANT NOTICE" letter dated May 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter recommends several precautions customers should use until Elekta finds a solution. Customers will be contacted when a solution is found.
Quantity in commerce: 27
Distribution: Nationwide Distribution-USA including the state of CT, FL, GA, IA, MN, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA , and WA.
Product codes and lots: 116001, 116012, 116044, EM7-008, 116055, 116064, 116014, 116052, 116023, 116056, 116053, 116047, 116043, 116051, 116070, 116122, 116063, 116020, EM7-003, EM-029, EM7-006, 116024, 116068, 116013, EM3-026, EM3-004, 116046

Product code MUJ

K001163Class IIDmlc IV-Ergo3D Line USA, Inc. / cleared 2000-10-23

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)