Z-2560-2019Class II

Monaco RTP System, 5.40 Unity, radiation treatment planning system

Name: Z-2560-2019 Monaco RTP System, 5.40 Unity, radiation treatment planning system
Creator: Elekta Inc
Published: 2019-09-04
License: https://open.fda.gov/license/

Elekta Limited / initiated 2019-09-04 / Open, Classified / root cause: software

FDA source

Elekta Inc began a recall of Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with... on 2019-09-04. FDA classified it as Class II and gives the reason as "It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation". 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-2560-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-09-04
Posted: 2019-09-25
Recalling firm: Elekta Limited
Product: Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
Root cause tag: software
FDA root cause: Software design
Action: The firm notified their consignees of the issue by email on 09/04/2019. The letter explained the problem and the workaround and requested the notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed and that all appropriate personnel working with the product be advised of the content of the letter.
Quantity in commerce: 30 units
Distribution: Worldwide Distribution - US Nationwide in the states of WI, OH, NY, OH, IN, IA, TX, and countries of Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, UK
Product codes and lots: UDI (01)00858164002190(10) 5.40.00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2560-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2560-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-10-02	2019-09-25
Z-2561-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-10-02	2019-09-25

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)