Z-2569-2011

Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 and above. Used to create treatment...

Name: Z-2569-2011 Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 and above. Used to create treatment...
Creator: Computerized Medical Systems Inc
Published: 2010-10-27
License: https://open.fda.gov/license/

Elekta Limited / initiated 2010-10-27 / Terminated / root cause: software

FDA source

Computerized Medical Systems Inc began a recall of Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 and above. Used to create treatment plans for any cancer patient for who external beam... on 2010-10-27. The reason FDA records is "Monaco: In XiO IMRT (Dynamic MLC Delivery) software, the radiation beam angle is set to zero. If different beam angles are selected via Monaco software, the beam angles will remain at zero". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2569-2011
Status: Terminated
Initiated: 2010-10-27
Posted: 2011-06-15
Terminated: 2014-04-02
Recalling firm: Elekta Limited
Product: Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 and above. Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Monaco: In XiO IMRT (Dynamic MLC Delivery) software, the radiation beam angle is set to zero. If different beam angles are selected via Monaco software, the beam angles will remain at zero.
Root cause tag: software
FDA root cause: Software design
Action: Computerized Medical Systems, Inc. sent a User Notice to the affected consignees on October 27, 2010, explaining the reason for correction, the clinical impact, and the workaround method. (VERIFY USE NOTICE DATE) A return postcard was included for the customer to confirm receipt of the User Notice. The firm intends for this issue to be corrected in Monaco Release 3.00 in March 2011.
Quantity in commerce: 11
Distribution: Worldwide Distribution - USA including CA, IL, MN, NM, OH, NY, TX, and WA and the Netherlands.
Product codes and lots: Release 2.04 and higher

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)