Z-2406-2021Class II

Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

Name: Z-2406-2021 Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Creator: Elekta Inc
Published: 2021-07-26
License: https://open.fda.gov/license/

Elekta Limited / initiated 2021-07-26 / Open, Classified

FDA source

Elekta Inc began a recall of Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 on 2021-07-26. FDA classified it as Class II and gives the reason as "If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2406-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-07-26
Posted: 2021-09-02
Recalling firm: Elekta Limited
Product: Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.
FDA root cause: Under Investigation by firm
Action: Elekta will send an Important Field Safety Notice 382-01-MON-019 to all affected customers beginning August 10, 2021. The notice informs users of the specific product and version numbers affected by the issue, and any workaround that can be used to avoid the issue. A copy of the Important Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. Customers are asked to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta representative as soon as possible, but no later than 30 days after receipt. This issue is expected to be addressed in a future Monaco release, tentatively scheduled for the end of June 2022.
Distribution: Distribution in US - IA, NJ, NY, TN, PA, TX, and WI OUS distribution in Australia, Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, Korea, Netherlands, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom
Product codes and lots: Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10 UDI: (01)00858164002190(10) 5.40.00 (01)00858164002190(10) 5.40.01 (01)00858164002190(10) 5.40.02 (01)00858164002268(10) 5.51.10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2406-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2406-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-08	2021-09-02

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)