XiO Radiation Treatment Planning System, XiO Release 4.3.0 and above Used to create treatment plans for any cancer patie

FDA device recall Z-2579-2011 · posted 2011-06-16 · Terminated

Recall details

Recalling firm

Computerized Medical Systems Inc

Reason for recall

XiO: When the beam template is recalled, XiO prematurely initiates a dose calculation, re-snaps the MLC or Port to the structure of the current patient , but then fails to re-calculate dose for the new MLC or Port position. If no subsequent change is made to force a dose recalculation, XiO will display the dose from the original MLC/Port shape dose instead of the dose from the re-snapped MLC/Port

Action taken

The firm, Elekta CMS Software, sent an "IMPORTANT SAFETY NOTICE" dated September 14, 2010 to its affected customers. The notice describes the product, problem and actions to be taken. The customers were instructed to distribute this notice to any all users of CMS software at their organization who are potentially affected by this issue, and complete and return the attached postcard to confirm receipt of the Safety Notice. The notice also states that this problem has existed since the XiO Release 4.3.0 and is resolved in the XiO release 4.26.00. Elekta will notify the customers when this solution is available. If you have any questions, please call 314-993-0003 or toll free 800-878-4267.

Root cause

Software design

Status

Terminated

Product code

MUJ

Quantity affected

1208

Distribution

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belarus, Belgium, Bolivia, Bosnia and Herzegovina

Date initiated

2010-10-03

Date posted

2011-06-16

Date terminated

2014-04-03

Location

Maryland Heights, MO

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