Jun

2011

Cl ll XiO Radiation Treatment Planning System

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

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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