Z-1825-2020Class II

Elekta MONACO RTP Sytem, radiation treatment planning software system -

Name: Z-1825-2020 Elekta MONACO RTP Sytem, radiation treatment planning software system -
Creator: Elekta Inc
Published: 2020-04-16
License: https://open.fda.gov/license/

Elekta Limited / initiated 2020-04-16 / Open, Classified / root cause: software

FDA source

Elekta Inc began a recall of Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with... on 2020-04-16. FDA classified it as Class II and gives the reason as "The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1825-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-04-16
Posted: 2020-04-29
Recalling firm: Elekta Limited
Product: Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.
Root cause tag: software
FDA root cause: Software design
Action: In April of 2020, Elekta Inc. prepared an Urgent/Important Field Safety Notice identifying this issue, the actions that should be taken by the user/customer in order to prevent risks for patients and/or users, and the actions planned by Elekta to correct the problem. PRODUCT: The Monaco RTP System with versions 5.40 or 5.40.01 installed in or after June of 2018. ACTIONS TO BE TAKEN BY THE CUSTOMER OR USER: Customers/users are instructed to follow their standard clinical practice of reviewing plans, including the review of contours and volumes. DVHs that show unexpected overdose or under-dose should be investigated by the customer/user. The customer/user should post the issued notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed and to advise the appropriate personnel who are working with this product on the content of this letter. Customers/users are also required to either acknowledge receipt of this notification via the Elekta Care Community or complete the provided acknowledgement form and return it to Elekta immediately upon receipt, but no later than within 30 days of receiving the notification letter.
Quantity in commerce: 96 devices
Distribution: Worldwide distribution - US Nationwide Distribution in the states of IA, NJ, NY, PA, TX, WI and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, United Kingdom.
Product codes and lots: Software Build: 5.40.00 (UDI: (01)00858164002190(10) 5.40.00), 5.40.01 (UDI: 01)00858164002190(10) 5.40.01)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1825-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1825-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-05-06	2020-04-29

Product code MUJ

K183037Class IIMonaco RTP SystemElekta, Inc. / cleared 2018-12-04

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)