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. Recall # Z-2604-2011

REASON
XiO Software: when a treatment machine is defined in Source File Maintenance (SFM), the MLC Model is set to Elekta, and beams using this treatment machine are added to a new plan in Teletherapy, XiO automatically adds an MLC to the beam. This is because the Elekta linac will always have an MLC in place when the plan is actually delivered.

RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter on May 20, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
57 units

DISTRIBUTION
Nationwide and Internationally

About the author

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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