FDA Medical Device Recalls (openFDA)
Computerized Medical Systems Inc: 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.
- Recall number
- Z-2564-2011
- Recalling firm
- Computerized Medical Systems Inc
- 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.
- Status
- Terminated
- Initiated
- 2010-05-31
- Posted
- 2011-06-14
- Terminated
- 2014-04-10
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Monaco Release 2.0.1 and above
- 510(k) numbers
- ["K071938","K091179"]
- PMA numbers
- not on file
- Product code
- MUJ
- Firm FEI
- 1937649
- Firm city
- Maryland Heights
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28