Aug

2011

Cl ll XiO Radiation Treatment Planning System

Company:Computerized Medical Systems Inc.
Date of Enforcement Report 8/3/11
Class ll:

PRODUCT
XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2407-2011

REASON
XiO Software: For a specific clinical setup, the MLC leaf positions on the exported DRR images might not match the MLC leaf positions displayed in XiO. One complaint was received.

RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter on May 27, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
415 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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