Z-0670-2020Class II

Monaco Radiation Treatment Planning System (RTP) System

Name: Z-0670-2020 Monaco Radiation Treatment Planning System (RTP) System
Creator: Elekta Inc
Published: 2019-11-22
License: https://open.fda.gov/license/

Elekta Limited / initiated 2019-11-22 / Open, Classified / root cause: software

FDA source

Elekta Inc began a recall of Monaco Radiation Treatment Planning System (RTP) System on 2019-11-22. FDA classified it as Class II and gives the reason as "Monaco is using the incorrect energy when optimizing and calculating 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-0670-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-11-22
Posted: 2019-12-12
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 using the incorrect energy when optimizing and calculating dose.
Root cause tag: software
FDA root cause: Software Design Change
Action: An Important Field Safety Notification letter is being emailed to affected customers beginning 11/22/2019. The letter identifies affected product, provides a description of the problem, and recommends user not use multiple energies within the same plan until a software fix has been applied to the device. A response form was asked to be returned. Affected customers are advised to contact local Elekta service teams for questions.
Quantity in commerce: 76 (7 US, 69 OUS)
Distribution: IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom.
Product codes and lots: Software Builds: 5.40.00, 5.50.00 and 5.51.00. UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002244(10) 5.50.00, and (01)00858164002268(10) 5.51.00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0670-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0670-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-18	2019-12-12

Product code MUJ

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)