XiO Radiation Treatment Planning System. XiO Release 4.50.00 and above Used to create treatment plans for any cancer pat
FDA device recall Z-2582-2011 · posted 2011-06-17 · Terminated
Recall details
- Recalling firm
- Computerized Medical Systems Inc
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 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, Cyr
- Date initiated
- 2010-11-16
- Date posted
- 2011-06-17
- Date terminated
- 2014-04-03
- Location
- Maryland Heights, MO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XIO RTP SYSTEM (K102216) | Computerized Medical Systems, Inc. | 2010-10-01 |