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.
This recall has been terminated (originally issued June 15, 2011).
- Company
- Computerized Medical Systems Inc
- Recall Initiated
- October 27, 2010
- Posted
- June 15, 2011
- Terminated
- April 2, 2014
- Recall Number
- Z-2569-2011
- Quantity
- 11
- Firm Location
- Maryland Heights, MO
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide Distribution - USA including CA, IL, MN, NM, OH, NY, TX, and WA and the Netherlands.
Lot / Code Info
Release 2.04 and higher
Root Cause
Software design
Action Taken
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.