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Terminated

XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

FDA Recall Z-2407-2011 · Posted 2011-06-02

Recalling FirmComputerized Medical Systems Inc
Recall StatusTerminated
Product CodeMUJ
Date Initiated2010-05-27
Date Terminated2014-04-10
Product Quantity415

Reason for Recall

XiO Software: For a specific clinical setup, the MLC leaf positions on the exported DRR images might not match the MLC leaf positions displayed in XiO.

Firm Action

The firm, Elekta, issued an "important Safety Notice" undated, to its customers. The notice indicates the problem and the clinical impact. There is no reasonable workaround for this issue. The notice states a future XiO Release will resolve the issue and the customers will be notified when this solution is available. A return postcard was included with the mailing to verify consignee received the notice. For sites not returning the postcard within one month, the recalling firm will contact them via phone or email to confirm receipt of the notice. The customers were instructed to distribute this notice to any and all users of the CMS software at their organization who are potentially affected by this issue. If you have any questions, please call 314-993-0003 or 800-878-4267.

Root Cause

Software design

Distribution Pattern

Nationwide distribution, including Puerto Rico, to medical facilities. Distribution was also made to Military and Government consignees. Foreign distribution was made to Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092132XIO RTP SYSTEMComputerized Medical Systems, Inc. · 2009-09-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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