—#124662

Product

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 product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K102216
Affected lot / code info: Model or Catalog No. MUJ; Software Version XiO Versions 4.80 and higher

Why it was recalled

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 (FDA determination)

Software Design Change

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter Ne, Ste 50, Atlanta, Georgia 30346-1227

Distribution

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.

Timeline

Recall initiated: 2013-11-25
Posted by FDA: 2014-01-17
Terminated: 2014-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124662. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.