Recall Z-2579-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Computerized Medical Systems Inc
XiO Radiation Treatment Planning System, XiO Release 4.3.0 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
| Date | Jun 16, 2011 (initiated Oct 3, 2010) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| Action | 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 |
| Quantity | 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, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Sa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092132 | XIO RTP SYSTEM Computerized Medical Systems, Inc., Sep 24, 2009 |