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.
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 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.
- 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
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