PlainRecalls
FDA Devices Moderate Class II 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.

Reported: January 29, 2014 Initiated: November 25, 2013 #Z-0780-2014

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.

Details

Recalling Firm
Elekta, Inc.
Units Affected
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.
Location
Atlanta, GA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Elekta, Inc.. Units affected: 13.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2014. Severity: Moderate. Recall number: Z-0780-2014.

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