Z-2564-2011

Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above Used to create treatment plans for...

Name: Z-2564-2011 Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above Used to create treatment plans for...
Creator: Computerized Medical Systems Inc
Published: 2010-05-31
License: https://open.fda.gov/license/

Elekta Limited / initiated 2010-05-31 / Terminated / root cause: software

FDA source

Computerized Medical Systems Inc began a recall of Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above Used to create treatment plans for any cancer patient for who external beam... on 2010-05-31. The reason FDA records is "Monaco: due to a software defect, the Radiological Depth (cm) and SSD to DRP (cm) parameters are reported incorrectly on the Beam Summary Report. This occurs for all Monaco IMRT plans". 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-2564-2011
Status: Terminated
Initiated: 2010-05-31
Posted: 2011-06-14
Terminated: 2014-04-10
Recalling firm: Elekta Limited
Product: Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 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: due to a software defect, the Radiological Depth (cm) and SSD to DRP (cm) parameters are reported incorrectly on the Beam Summary Report. This occurs for all Monaco IMRT plans.
Root cause tag: software
FDA root cause: Software design
Action: Computerized Medical System sent a "USER NOTICE" letter dated June 24, 2010, to all affected users. This notice identified the product, the problem, and the actions to be taken. There is no current workaround. All customers will be mailed a postcard to be returned as proof of receipt and understanding of the notification. Consignees will be contact via telephone or e-mail after June 30, 2010 if the postcard is not returned This notice is to be distributed to any and all users of CMS software at your organization who are potentially affected. The notice states the issue will be resolved in Monaco Release 2.04, but no date for this release was given. For further questions, please call (403) 830-8023
Quantity in commerce: 62
Distribution: Worldwide Distribution -- USA (nationwide) and the countries of Australia, Austria, Belgium, China, Finland, France, Germany, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, Switzerland, Taiwan, Thailand and United Kingdom.
Product codes and lots: Monaco Release 2.0.1 and above

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)