Elekta, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0780-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: November 25, 2013

Date Posted: January 29, 2014

Recall Number: Z-0780-2014

Event ID: 67078

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.

Status: Terminated

Product Quantity: 13

Code Information:

Model or Catalog No. MUJ; Software Version XiO Versions 4.80 and higher

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.

Voluntary or Mandated:

Voluntary: Firm initiated