Company: Computerized Medical Systems Inc.
Date of Enforcement Report 8/31/11
Class ll:
PRODUCT
XiO Radiation Treatment Planning System, XiO versions equal to or greater than 2.4.0 and less than 4.63.0 The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2919-2011
REASON
The XiO Software currently prompts for entry of CT to ED data for a studyset. No indication is given that the Electron Density data should only be used for Photon and Electron calculations and either Relative Stopping Power or Mass Density should be used for Proton calculations (depending on the algorithm).
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter dated May 18, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Nationwide and Germany
