25

Aug

2011

Focal Radiation Treatment Planning System Cl ll

0

Company: Computerized Medical Systems Inc.
Date of Enforcement Report 8/24/11
Class ll:

PRODUCT
Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system. Recall # Z-2592-2011

REASON
Focal: for XiO plans calculated in relative dose mode, the Focal Plan Review application will display the DVH and maximum dose correctly. However, the isodose display is not scaled correctly. If the user evaluated the plan based only on the isodose display, they might misinterpret the actual dose delivered to the patient.

RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letter beginning on May 21, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
308 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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