Recall Z-0780-2014 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
| Date | Jan 17, 2014 (initiated Nov 25, 2013) |
| Status | Terminated |
| Reason | When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan. |
| Root cause | Software Design Change |
| Action | An Important Safety Notice, LINXIO0017 Proton Sport Beams, Changes in Fractionation not Updating Dose, is in the process of being distributed to affected customers. The release date for this notice is November 25, 2013. The notice included a Confirmation of Receipt which was to be returned to Elekta. For further questions please call (404) 993-5886. |
| Quantity | 13 |
| Distribution | Worldwide Distribution - US Distribution including the states of IL, IN, LA, NJ, TX, WA and WI., and the countries of Belgium, Germany, Italy and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102216 | XIO RTP SYSTEM Computerized Medical Systems, Inc., Oct 1, 2010 |