Recall Z-2569-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Computerized Medical Systems Inc
Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 and above. Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed.
| Date | Jun 15, 2011 (initiated Oct 27, 2010) |
| Status | Terminated |
| Reason | Monaco: In XiO IMRT (Dynamic MLC Delivery) software, the radiation beam angle is set to zero. If different beam angles are selected via Monaco software, the beam angles will remain at zero. |
| Root cause | Software design |
| Action | Computerized Medical Systems, Inc. sent a User Notice to the affected consignees on October 27, 2010, explaining the reason for correction, the clinical impact, and the workaround method. (VERIFY USE NOTICE DATE) A return postcard was 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 | 11 |
| Distribution | Worldwide Distribution - USA including CA, IL, MN, NM, OH, NY, TX, and WA and the Netherlands. |
| FDA record | Open on fda.gov |