Computerized Medical Systems Inc Monaco Radiation Treatment Planning System, Monaco Release 1.0.0 through 1.0.2. Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Monaco Radiation Treatment Planning System, Monaco Release 1.0.0 through 1.0.2. Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed.
Brand
Computerized Medical Systems Inc
Lot Codes / Batch Numbers
XiO Release 1.0.0 through 1.0.2 All lot or serial numbers
Products Sold
XiO Release 1.0.0 through 1.0.2 All lot or serial numbers
Computerized Medical Systems Inc is recalling Monaco Radiation Treatment Planning System, Monaco Release 1.0.0 through 1.0.2. Used to create tre due to Monaco: If the user selects Monte Carlo Photon as the Secondary Algorithm (to be used for final dose calculation through segments), and selects SKIP . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Monaco: If the user selects Monte Carlo Photon as the Secondary Algorithm (to be used for final dose calculation through segments), and selects SKIP Forward button at any time during stage 2 optimization, the system may only use the pencil beam algorithm for final computation of dose even though Monte Carlo was selected. Other than specific output to the console window, there will be no other in
Recommended Action
Per FDA guidance
Computerized Medical Systems, Inc. sent a "MONACO CUSTOMER ADVISORY" letter dated June 2008 to all affected customers. The letter describes the product, problem, and the action to be taken. The customer was instructed to use caution when using the Skip Forward button in stage 2 according to written instructions provided in the letter. This defect exists in Monaco Release 1.0.0 through 1.0.2 and will be resolved as soon as possible. Note: The issue was resolved in Monaco Release 2.0.1 and above. Questions should be directed to the manufacturer's representative telephone number at 408-830-8023.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026