Company: Computerized Medical Systems Inc.
Date of Enforcement Report 6/8/2011
Class ll:
PRODUCT
XiO Radiation Treatment Planning System, XiO Release 1.0.2 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2408-2011
REASON
XiO Software is not transferring the correct information regarding coordinates for the radiation beam. The coordinates may not be accurate. If all the information is transferred at once, the information appears to be correct. If something is changed, edited, or the information is transmitted in parts, the coordinate information may not be accurate. Two patients were mistreated.
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letters beginning September 2010. Firm initiated recall is ongoing..
VOLUME OF PRODUCT IN COMMERCE
1,377 units
DISTRIBUTION
Nationwide and Internationally
