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U.S. Department of Health and Human Services

Class 2 Device Recall Elekta XiO Radiation Treatment Planning System

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 Class 2 Recall
Elekta XiO Radiation Treatment Planning System
see related information
Date Posted May 26, 2010
Recall Status1 Terminated on June 07, 2012
Recall Number Z-1655-2010
Recall Event ID 55361
Premarket Notification
510(K) Number
K092132 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product Elekta XiO Radiation Treatment Planning System
Code Information Release 4.50.00 and above
Recalling Firm/
Manufacturer
Computerized Medical Systems Inc
13723 Riverport Dr Ste 100
Maryland Heights, Missouri 63043-4819
For Additional Information Contact Christopher Ivicevich
314-993-0003
Manufacturer Reason
for Recall
Under certain circumstances, XiO will over-estimate dose in the region where the backup jaw is inside the MLC opening
FDA Determined
Cause 2
DESIGN: Software Design
Action Elekta issued an undated "Important Safety Notice" to all affected sites via e-mail on 4/20/2010. The notice was also sent to the sites on 4/6/10 and 4/12/10 (for 4 sites) before the firm made the decision to recall. The letter explains the correct functioning of the system, the problem, when and why it occurs, the clinical impact, and the work around. Although not stated in the Safety Notice, a self-addressed postcard was enclosed for the customer to return as evidence they received and understood the notice. Sites that do not return the card will be contacted by phone.
Quantity in Commerce The release is being used by 34 customers that also have an Elekta linear accelerator
Distribution Worldwide Distribution: USA, Canada, Australia, Spain, Italy, the Netherlands, United Kingdom, Taiwan, Malaysia, France, Ireland, and Israel.
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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