Z-2157-2013Class II

DMLC IV-ERGO - Beam shaping block for Radiation Therapy

Name: Z-2157-2013 DMLC IV-ERGO - Beam shaping block for Radiation Therapy
Creator: Elekta, Inc.
Published: 2013-08-15
License: https://open.fda.gov/license/

Elekta Limited / initiated 2013-08-15 / Terminated / root cause: design

FDA source

Elekta, Inc. began a recall of DMLC IV-ERGO - Beam shaping block for Radiation Therapy on 2013-08-15. FDA classified it as Class II and gives the reason as "Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect". 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-2157-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-15
Posted: 2013-09-04
Terminated: 2015-07-28
Recalling firm: Elekta Limited
Product: DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
Product code: IXI Block, Beam-Shaping, Radiation Therapy
Reason for recall: Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.
Root cause tag: design
FDA root cause: Device Design
Action: Important Field Safety Notices 200 01 406 030 (Changes to your system to improve the safe operation of DMLC) and 200 01 602 031 (Changes to your system to improve the safe operation of 3DLINE DMLC) letters were sent to customers on 8/15/2013 advising them of the issue and recommendations to resolve either by upgrading their system or to discontinue a clinical use of the device.
Quantity in commerce: 31
Distribution: Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico.
Product codes and lots: EM-042, EM7-004, EM-046, EM-060, EM-047, EM-029, EM7-003, EM7-002, EM7-008, EM-062, EM-063, EM3-004, 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116068, 116013, 116046

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2157-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2157-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-11	2013-09-04

Product code IXI

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)