Recall Z-2598-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
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.
| Date | Jun 20, 2011 (initiated Jan 13, 2011) |
| Status | Terminated |
| 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, Fra |
| FDA record | Open on fda.gov |