Recall Z-0928-2014 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
| Date | Feb 4, 2014 (initiated Nov 25, 2013) |
| Status | Terminated |
| Reason | When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect. |
| Root cause | Software design |
| Action | Corrective Action 1 - An important safety notice, LINXIO0018 - Incorrect Effective Depth for Bolused Beams is in the process of being distributed to affected customers. (Release date November 25, 2013). Corrective Action 2 - Develop a fix to the defect in an expeditious timeframe and make available in Patch Release 4.0.03 and Release 5.00.01. |
| Quantity | 1424 |
| Distribution | Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, QA, WA, WV, WI, and WY, and the countries of Albania, Algeria, Ar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102216 | XIO RTP SYSTEM Computerized Medical Systems, Inc., Oct 1, 2010 |