• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall XiO Radiation Treatment Planning System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
XiO Radiation Treatment Planning System
see related information
Date Posted March 25, 2010
Recall Status1 Terminated on August 24, 2011
Recall Number Z-1209-2010
Recall Event ID 55008
Premarket Notification
510(K) Number
K092132 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product XiO Radiation Treatment Planning System, Release 4.51.00.
Code Information Release 4.51.00
Recalling Firm/
Manufacturer
Computerized Medical Systems Inc
13723 Riverport Drive
Suite 100
Maryland Heights, Missouri 63043
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Christopher Ivicevich
408-830-8023
Manufacturer Reason
for Recall
Inconsistent MLC positions, dose, and monitor units
FDA Determined
Cause 2
DESIGN: Software Design
Action Elekta contacted customers by phone and mail beginning February 22, 2010, explaining the affected product and providing software update information. For further information, contact Elekta at 1-408-830-8023.
Quantity in Commerce Planning system is loaded 25 in locations
Distribution Worldwide Distribution -- United States (PA, AZ, CA, MN, OH, WI, NC, FL, TX, NY and WI), Australia, The Netherlands and India.
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.
-
-