Z-0978-2014Class II

Dmlc IV-Ergo

Name: Z-0978-2014 Dmlc IV-Ergo
Creator: Elekta, Inc.
Published: 2013-05-01
License: https://open.fda.gov/license/

Elekta Limited / initiated 2013-05-01 / Terminated / root cause: design

FDA source

Elekta, Inc. began a recall of DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific... on 2013-05-01. FDA classified it as Class II and gives the reason as "It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems". 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-0978-2014
Classification: Class II
Status: Terminated
Initiated: 2013-05-01
Posted: 2014-02-25
Terminated: 2015-01-29
Recalling firm: Elekta Limited
Product: DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
Product code: IXI Block, Beam-Shaping, Radiation Therapy
Reason for recall: It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
Root cause tag: design
FDA root cause: Component design/selection
Action: Elekta sent an Important Field Safety Notice letter dated May 2013 to affected customers. The letter identified the scope, problem, clinical impact, solution, and safety reference. For question call +44 (0)1293 544422
Quantity in commerce: 35 units
Distribution: US Nationwide Distribution in the states of CT, FL, GA, IA, MO, NY, ND, OK, RI, TX, VA, WA
Product codes and lots: Identifier : 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116063, 116068, 116013, 116046

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0978-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0978-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-24

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)