Jun

2011

Cl ll XiO Radiation Treatment Planning System

Company:Computerized Medical Systems Inc
Date of Enforcement Report 6/22/2011
Class ll:

PRODUCT
XiO Radiation Treatment Planning System, XiO Release 4.3.1 through 4.40.00. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2567-2011

REASON
XiO Software: Under certain conditions, when the port shape is altered, dose is not recalculated. The port-change flag is not being set correctly when the port shape is regenerated. The dose distribution will not match the blocking displayed and the mis-match might not be obvious. Monitor Unit calculations will also be based on an incorrect dose distribution. This problem has existed since Release 4.3.1.

RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, letter dated December 8, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
784 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl ll XiO Radiation Treatment Planning System

Amy Sellers

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