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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 Device Recall Elekta XiO Radiation Treatment Planning Systemsee related information
Date Initiated by FirmApril 15, 2010
Date PostedMay 26, 2010
Recall Status1 Terminated 3 on June 07, 2012
Recall NumberZ-1655-2010
Recall Event ID 55361
510(K)NumberK092132 
Product Classification Radiation Treatment Planning System - Product Code MUJ
ProductElekta 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 MO 63043-4819
For Additional Information ContactChristopher 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		Software design
ActionElekta 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 CommerceThe release is being used by 34 customers that also have an Elekta linear accelerator
DistributionWorldwide Distribution: USA, Canada, Australia, Spain, Italy, the Netherlands, United Kingdom, Taiwan, Malaysia, France, Ireland, and Israel.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MUJ
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