Recall Z-0130-2016 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
| Date | Aug 31, 2015 |
| Status | Terminated |
| Reason | Incorrect Treatment Delivery Using Third Party Fixed Wedges. |
| Root cause | Software design |
| Action | Consignees were notified via URGENT FIELD SAFETY ALERT, on 08/31/2015. |
| Quantity | 1440 units |
| Distribution | Worldwide Distribution-Domestic: AK, AL, AZ, CA, CO, CT, DC, FL, IN, IL, KY, MA, MD, MI, MN, MO, NJ, NC, ND, NY, OH, OK, PA, PR, TN, TX, VA, WA and WI; International: Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Can |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102216 | XIO RTP SYSTEM Computerized Medical Systems, Inc., Oct 1, 2010 |