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XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for...

FDA Recall #Z-0780-2014 — Class II — November 25, 2013

Recall #Z-0780-2014 Date: November 25, 2013 Classification: Class II Status: Terminated

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.

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.

Recalling Firm

Elekta, Inc. — Atlanta, GA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product 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.

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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