Recall Z-2582-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Computerized Medical Systems Inc
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 of brachytherapy has been prescribed.
| Date | Jun 17, 2011 (initiated Nov 16, 2010) |
| Status | Terminated |
| Reason | XiO: When a new electron beam is added to a plan, the calculation Algorithm is set to Pencil Beam, and an Aperture is added to the beam, the user can select Port-Port Properties and edit the Material Thickness values. If the algorithm is then changed to Monte Carlo, the calculation will proceed and the user is not warned the Material/Thickness values just entered are not used in the dose calculati |
| Root cause | Other |
| Action | Elekta CMS Software drafted a User Notice which explains the reason for correction, the clinical impact, and the workaround method. The User Notice was distributed to all affected sites in November 2010. The issue will be resolved in the XiO Release 4.70.00, expected to be available in July 2011. |
| Quantity | 556 |
| Distribution | Worldwide Distribution - USA (nationwide, Washington, DC and Puerto Rico and the countries of Albania, Algeria, Australia, Austria, Bahamas, Belarus, Belgium, Brazil, Canada, Chile, China,Croatia, Cyrus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102216 | XIO RTP SYSTEM Computerized Medical Systems, Inc., Oct 1, 2010 |