FDA Recall Terminated

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.

Recall: Z-0780-2014 · Initiated November 25, 2013

Recall

Recall Number
Z-0780-2014
Event Number
67078
Firm
Elekta, Inc.
FEI Number
1037831
Product Code
MUJ
Status
Terminated
Root Cause
Software Design Change
Initiated
November 25, 2013
Posted
January 17, 2014
Terminated
May 13, 2014
Address
400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227

Description

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.

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.

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.

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.

Quantity

13