Company: Computerized Medical Systems Inc.
Date of Enforcement Report 8/24/11
Class ll:
PRODUCT
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. Recall # Z-2569-2011
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.
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter on October 27, 2010. FDA initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Nationwide and the Netherlands