Z-2409-2019Class II

Monaco Radiation Treatment Planning System (RTP) System

Name: Z-2409-2019 Monaco Radiation Treatment Planning System (RTP) System
Creator: Elekta, Inc.
Published: 2019-08-23
License: https://open.fda.gov/license/

Elekta Limited / initiated 2019-08-23 / Terminated / root cause: design

FDA source

Elekta, Inc. began a recall of Monaco Radiation Treatment Planning System (RTP) System on 2019-08-23. FDA classified it as Class II and gives the reason as "Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions". 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-2409-2019
Classification: Class II
Status: Terminated
Initiated: 2019-08-23
Posted: 2019-08-28
Terminated: 2024-06-28
Recalling firm: Elekta Limited
Product: Monaco Radiation Treatment Planning System (RTP) System
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.
Root cause tag: design
FDA root cause: Device Design
Action: Elekta Inc. notified customers on about 08/23/2019 via "IMPORTANT FIELD SAFETY NOTIFICATION" letter. The letter informed customers that the Monaco is displaying some incorrect shift information on the Scan and Setup Reference Report and is DICOM exporting incorrect shift information. Instructions included that all shifts should be verified before treatment, that a software fix is planned. Customer were also instructed to post the notice in a place accessible to all users, advise personnel working with the device of the issue, and to complete and return the Acknowledgement Form provided.
Quantity in commerce: 49 units
Distribution: Distribution within the US to Ohio and Indiana. International distribution to Germany, Greece, Sweden.
Product codes and lots: Software Build: 5.50.00 & 5.51.00; UDI GTIN: (01)00858164002244(10) 5.50.00, (01)00858164002268(10) 5.51.00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2409-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2409-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-27

Product code MUJ

K190178Class IIMonaco RTP SystemElekta, Inc. / cleared 2019-03-29

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)