Jun

2012

Cl ll XiO Radiation Treatment Planning

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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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

Amy Sellers

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