FDA Medical Device Recalls (openFDA)
Computerized Medical Systems Inc: Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. The Monaco RTP system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed.
- Recall number
- Z-2561-2011
- Recalling firm
- Computerized Medical Systems Inc
- Product
- Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. The Monaco RTP system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed.
- Status
- Terminated
- Initiated
- 2011-01-13
- Posted
- 2011-06-14
- Terminated
- 2014-04-03
- Reason
- Monaco: For VMAT plans, the measured dose of radiation delivered is lower than the software calculated dose by about 5% in Monaco Release 2.03.00 and 2.04.00.
- Root cause
- Software design
- Action
- Computerized Medical Systems, Inc. sent a "USER NOTICE" on January 13, 2011, to all affected users. This notice identified the product, the problem, and the action needed to be taken by the customer. A return postcard is included for the customer to confirm receipt of the user notification. The firm intends for correction in the dose calulation engine to appear in the Monaco Release 3.00 in March 2011. Any further questions please call (403) 830-8023.
- Quantity
- 94
- Distribution
- Worldwide Distribution-- USA (nationwide) and countries of Austria, Australia, Belarus, Canada, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Singapore, Slovenia, South Korea, Spain, Switzerland, Taiwan, Thailand and UK.
- Lot, serial or model codes
- Release 2.03.00 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