Z-0234-2018Class II

Elekta ERGO++

Name: Z-0234-2018 Elekta ERGO++
Creator: Elekta Inc
Published: 2017-09-01
License: https://open.fda.gov/license/

Elekta Limited / initiated 2017-09-01 / Terminated / root cause: manufacturing process

FDA source

Elekta Inc began a recall of Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments on 2017-09-01. FDA classified it as Class II and gives the reason as "Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0234-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-01
Posted: 2017-12-13
Terminated: 2019-11-05
Recalling firm: Elekta Limited
Product: Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Elekta sent an Urgent Important Field Safety Notification letter dated September, 2017. The letter identified affected product, problem and actions to be taken. Customers were instructed that a copy of the Important Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. The customers were asked to complete the verification tests and return the Important Field Safety Notice Acknowledgment form to their local Elekta representative as soon as possible but no later than 30 days from receipt. For questions contact your local Elekta Care Support Center.
Quantity in commerce: 182
Distribution: Worldwide Distribution - US Nationwide in the states of: VA, CA, TX, MO, NY, WA, NM, MA, FL, CT, OK, SC, MS, NY, GA, NC and the countries of: AUSTRALIA, BANGLADESH, BRAZIL, BULGARIA, CANADA, COLOMBIA, CZECH REPUBLIC, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ITALY, JAPAN, JORDAN, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, PERU, PHILIPPINES, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, TAIWAN, THAILAND, TURKEY, VENEZUELA, and VIETNAM
Product codes and lots: Version 1.7.3 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0234-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0234-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-12

Product code MUJ

K080601Class IIErgo++ Version 1.73D Line Medical Systems S.R.L. / cleared 2008-06-06

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)