FDA Medical Device Recalls (openFDA)
Computerized Medical Systems Inc: Monaco Radiation Treatment Planning Workstation, Monaco Release 2.03.00 and above To create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed.
- Recall number
- Z-2598-2011
- Recalling firm
- Computerized Medical Systems Inc
- Product
- Monaco Radiation Treatment Planning Workstation, Monaco Release 2.03.00 and above 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
- 2011-06-20
- Terminated
- 2014-04-02
- Reason
- Monaco: When the isocenter location is edited in the IMRT Activity screen, the shift coordinates are not updated in the IMRT Plan report.
- Root cause
- Software design
- Action
- Computerized Medical Systems Inc drafted a User Notice which explains the reason for correction, the clinical impact, and the workaround method. The User Notice was sent January 13, 2011. A return postcard is 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
- 137
- Distribution
- Worldwide Distribution - USA (Nationwide distribution to AK, AZ, CA, CO, FL, IL, IN, MA, MI, MN, MO, NC, NM, NY, OH, OR, PA, SC, TX, VA, WA, and WI and the countries of Algeria, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Phillipines, Poland, Portugal, Singapore, Slovenia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and the United Kindom.
- Lot, serial or model codes
- Monaco Release 2.03.00and 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
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
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 3e6df46828c1, published 2026-10-06