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U.S. Department of Health and Human Services

Class 2 Device Recall XiO Radiation Treatment Planning System

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 Class 2 Recall
XiO Radiation Treatment Planning System
see related information
Date Posted June 16, 2011
Recall Status1 Terminated on April 08, 2014
Recall Number Z-2577-2011
Recall Event ID 58210
Premarket Notification
510(K) Number
K092132 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product XiO Radiation Treatment Planning System, XiO Release 4.0.0 through 4.40.00 Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
Code Information XiO Release 4.0.0 through 4.40.00
Recalling Firm/
Manufacturer
Computerized Medical Systems Inc
13723 Riverport Drive
Suite 100
Maryland Heights, Missouri 63043
For Additional Information Contact Christopher Ivicevich
408-380-8023
Manufacturer Reason
for Recall
XiO: When the patient is positioned with their feet toward the CT gantry, the coordinates exported to the LAP IsoMark laser positioning system are not correct.
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm, CMS, Inc., sent a "XiO Customer Advisory" letter dated April 8, 2008 to all affected customers. The letter describes the product, the problem, and the actions to be taken ( workaround). The letter also states the problem will be resolved in a future release. No release number or date was given. If you have any questions, please call 408-380-8023.
Quantity in Commerce 75
Distribution Worldwide distribution: USA (nationwide) and countries of: China, France, Germany, Japan, Mongolia, Netherlands, Nicaragua, Poland, Russia, South Korea, Switzerland, and Turkey.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = COMPUTERIZED MEDICAL SYSTEMS, INC.
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