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.
FDA Recall Z-0780-2014 · Posted 2014-01-17
Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2013-11-25
Date Terminated2014-05-13
Product Quantity13
Reason for Recall
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.
Firm 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.
Root Cause
Software Design Change
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.