Z-2091-2019Class II

Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System

Name: Z-2091-2019 Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Creator: Elekta Inc
Published: 2019-07-03
License: https://open.fda.gov/license/

Elekta Limited / initiated 2019-07-03 / Open, Classified

FDA source

Elekta Inc began a recall of Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System on 2019-07-03. FDA classified it as Class II and gives the reason as "When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2091-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-07-03
Posted: 2019-07-27
Recalling firm: Elekta Limited
Product: Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.
FDA root cause: Under Investigation by firm
Action: Elekta began distribution of their Important Field Safety Notice to all affected customers from 07/03/2019 by email. The notice informs users of the specific product and version numbers affected by the issue, and any work-arounds that can be used to avoid the issue. The problem will be resolved in a future Monaco software release.
Quantity in commerce: 1396 units
Distribution: worldwide
Product codes and lots: all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2091-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2091-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-08-07	2019-07-27

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)