Z-2563-2021Class II

Elekta Monaco -

Name: Z-2563-2021 Elekta Monaco -
Creator: Elekta Inc
Published: 2021-09-14
License: https://open.fda.gov/license/

Elekta Limited / initiated 2021-09-14 / Open, Classified / root cause: software

FDA source

Elekta Inc began a recall of Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy on 2021-09-14. FDA classified it as Class II and gives the reason as "Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set". 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-2563-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-14
Posted: 2021-09-24
Recalling firm: Elekta Limited
Product: Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
Root cause tag: software
FDA root cause: Software design
Action: A Recall notification letter titled, "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" was sent to consignees on 09/14/2021 via email. The letter instructs the consignee of the following: "When using Monaco in offline mode, ensure that the active image set is selected in the workspace control when using the Auto Margin tool." The consignee is to post the notice in a place that is accessible to all users until the action is closed. Furthermore, the consignee is to advise the appropriate personnel, working with this product, on the content of the letter. The firm is requesting that the consignee submit an acknowledgement form as well via the Elekta Care" Community or complete the form and return it to Elekta immediately upon receipt, but no later than within 30 days.
Quantity in commerce: 214 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of PA, MI, WI, NY, TN, NJ, IA, TX and the countries of United Kingdom, Turkey, Switzerland, Sweden, Spain, Netherlands, Korea, Thailand, Japan, Italy, Hong Kong, Germany, France, Denmark, China, Canada, Belgium, Bahrain, Australia.
Product codes and lots: Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10; UDI GTIN: (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-2563-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2563-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-10-06	2021-09-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)