Z-0181-2016Class II

Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for...

Name: Z-0181-2016 Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for...
Creator: Elekta, Inc.
Published: 2015-10-16
License: https://open.fda.gov/license/

Elekta Limited / initiated 2015-10-16 / Terminated

FDA source

Elekta, Inc. began a recall of Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy on 2015-10-16. FDA classified it as Class II and gives the reason as "Unintended update of Dose and MU and Incorrect Assignment of Bolus". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0181-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-16
Posted: 2015-10-30
Terminated: 2017-04-04
Recalling firm: Elekta Limited
Product: Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Unintended update of Dose and MU and Incorrect Assignment of Bolus.
FDA root cause: Other
Action: Elekta sent Important Field Safety Notice 382-01-MON-003 to all customers on 10/16/2015. The notice informs users of the specific product and version numbers affected by both issues. The affected devices for both issues are those running Monaco 5.10.01. Customers are instructed to complete and return acknowledgement form. Solution/fix has been released in Monaco patch 5.10.02 and all affected users will be made aware of its availability by the end of October 2015.
Quantity in commerce: 154
Distribution: CA, IN, MI,MO, TX, WI, Australia, Canada, Germany,m Greece, India, Netherlands, New Zealand, Turkey and United Kingdom
Product codes and lots: Software Version 5.10.01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0181-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0181-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-04	2015-10-28

Product code MUJ

K151233Class IIMonacoImpac Medical Systems, Inc. / cleared 2015-07-07

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)