The Recall Desk
HighFDA (Devices)·Z-1082-2014·Announced 2014-03-12

Elekta Desktop Pro Linear Accelerator Control Software Recalled for Calibration Errors

Elekta, Inc. is recalling Desktop Pro linear accelerator control software because incorrect values may be entered during calibration procedures.

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 radiation therapy where a software error could lead to incorrect treatment delivery. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Elekta, Inc. is recalling 1,309 units of Desktop Pro linear accelerator control software. The software is intended to assist licensed practitioners in delivering radiation to defined target volumes.

The recall is due to a potential for incorrect values to be typed or inverted during treatment table, gantry, and collimator calibration procedures. This error could affect the accuracy of the radiation delivery process.

The affected software versions are 6.0, 6.1.0, and 7.0.1. The products were distributed worldwide, including the United States and numerous international countries. Users should contact Elekta, Inc. for further instructions regarding the recall.

The recalled product

Product
Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
Manufacturer
Elekta, Inc.
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
1,309

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 (3)

  • Identifier - 6.0
  • 6.1.0
  • 7.0.1

Distribution

Distributed nationwide across the United States.

The notice also names 46 states specifically:

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