The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1197-2014·Announced 2014-03-19

Elekta XiO RPT System Recalled for Incorrect Dose Calculations

Elekta is recalling the XiO RPT System because dose and monitor unit values are not computed correctly when specific wedges are used with dynamic arcs.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 with a defect that could lead to incorrect radiation dosing, which is a risk-of-harm product where injury has not yet been reported in the source text.

Plain-English summary

Elekta, Inc. is recalling the XiO RPT System, a medical device used to create treatment plans for cancer patients prescribed external beam radiation therapy or brachytherapy. The system calculates and displays radiation dose distributions for patients.

The recall is due to a software defect where dose and monitor unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs. This error affects versions 4.1 and higher of the system.

The recall covers 1,776 units distributed across the United States, Puerto Rico, and numerous international locations. Healthcare providers using this system should contact Elekta for further instructions on correcting the calculation errors.

The recalled product

Product
XiO RPT 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…
Manufacturer
Elekta, Inc.
Category
Medical Device — Radiation Therapy Planning
Hazard
Affected units
1,776

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)

  • Versions 4.1 and higher

Distribution

Distributed in 42 states:

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