Company:Computerized Medical Systems Inc.
Date of Enforcement Report 6/6/12
Class ll:
PRODUCT
XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up. Recall # Z-1644-2012
REASON
XiO will underestimate the dose delivered when the closed leaf gap is set to 0mm on XiO and a value other than 0mm is set on the accelerator.
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter the week of April 30, 2012. Firm initiated recall is on going.
VOLUME OF PRODUCT IN COMMERCE
1,652 sites
DISTRIBUTION
Nationwide and Canada
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