Recall Z-2560-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
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.
| Date | Jun 14, 2011 (initiated Jun 30, 2008) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| Action | 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 408-830-80 |
| Quantity | 47 |
| Distribution | Worldwide Distribution-- USA (nationwide) including the states of IL, MI, MO, OR, SC, TX, VA, and Puerto Rico and the countries of Canada, China, Cyprus, Estonia, France, Germany, Greece, Italy, Japan, Netherlands, Philippines, Poland, Portugal, Slovenia, South Korea, Spain, and United Kingdom. |
| FDA record | Open on fda.gov |