XiO Radiation treatment Planning System, XiO Release 4.2.0 and above Usage: Used to create treatment plans for any cance

FDA device recall Z-2578-2011 · posted 2011-06-16 · Terminated

Recall details

Recalling firm

Computerized Medical Systems Inc

Reason for recall

When a dialog box is displayed and the dose status is changed to "Dose not current", beam edits can be made in the graphics area using the mouse (rotate collimator, reposition collimator, move isocenter, move weight point, etc.). Then if CANCEL is selected on the dialog box, any edits made on the dialog box are undone, the dose is left unchanged, but the beam edits made in the graphics area with t

Action taken

The firm, Elekta CMS Software, sent an "IMPORTANT SAFETY NOTICE" dated September 6, 2010 to its affected customers. The notice describes the product, problem and actions to be taken (workaround). The customers were instructed to distribute this notice to any and all users of CMS software at their organization who are potentially affected by this issue. The notice also states that this problem has existed since XiO Release 4.2.0 and will be resolved in XiO Release 4.70.00. Elekta will notify the sites 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

1293

Distribution

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

Date initiated

2010-09-17

Date posted

2011-06-16

Date terminated

2014-04-08

Location

Maryland Heights, MO

Related 510(k) clearances