The Recall Desk
HighFDA (Devices)·Z-0130-2016·Announced 2015-10-28

Elekta XiO Radiation Treatment Planning System Recalled for Incorrect Treatment Delivery

Elekta is recalling 1,440 XiO Radiation Treatment Planning Systems because they may deliver incorrect treatments when using third-party fixed wedges.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for cancer treatment where incorrect delivery poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Elekta, Inc. is recalling 1,440 units of the XiO Radiation Treatment Planning System, version 4.51 and higher. The system is used to create treatment plans for cancer patients prescribed external beam radiation therapy or brachytherapy.

The recall is due to a risk of incorrect treatment delivery when the system is used with third-party fixed wedges. The affected units were distributed worldwide, including in the United States and numerous international locations.

Healthcare facilities should contact Elekta, Inc. for further instructions on how to address this issue.

The recalled product

Product
XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Manufacturer
Elekta, Inc.
Category
Medical Device — Radiation Therapy Planning
Hazard
Affected units
1,440

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Version 4.51 and higher

Distribution

Distributed in 29 states:

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