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U.S. Department of Health and Human Services

Class 2 Device Recall XiO RTP System

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  Class 2 Device Recall XiO RTP System see related information
Date Initiated by Firm November 25, 2013
Date Posted January 17, 2014
Recall Status1 Terminated 3 on May 13, 2014
Recall Number Z-0780-2014
Recall Event ID 67078
510(K)Number K102216  
Product Classification System,planning,radiation therapy treatment - Product Code MUJ
Product XiO RTP System

The XiO RTP System is 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.
Code Information Model or Catalog No. MUJ; Software Version XiO Versions 4.80 and higher
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Linda Wetsel
404-993-5886
Manufacturer Reason
for Recall		 When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan.
FDA Determined
Cause 2		 Software Design Change
Action An Important Safety Notice, LINXIO0017 Proton Sport Beams, Changes in Fractionation not Updating Dose, is in the process of being distributed to affected customers. The release date for this notice is November 25, 2013. The notice included a Confirmation of Receipt which was to be returned to Elekta. For further questions please call (404) 993-5886.
Quantity in Commerce 13
Distribution Worldwide Distribution - US Distribution including the states of IL, IN, LA, NJ, TX, WA and WI., and the countries of Belgium, Germany, Italy and Netherlands.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = COMPUTERIZED MEDICAL SYSTEMS, INC.
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