Elekta Agility Software Recall for Calibration Input Errors
Elekta is recalling Agility software version 3.0 because incorrect values can be entered during calibration procedures for medical linear accelerators.
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 high-risk medical device where a software error could lead to incorrect calibration, representing a risk of harm even though no injuries have been reported.
Plain-English summary
Elekta, Inc. is recalling Agility, version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators. This software is associated with Agility collimators. The recall involves 300 units distributed worldwide, including the United States, DC, Puerto Rico, and numerous international countries.
The recall is due to a risk that incorrect values may be typed or a value may be inverted during treatment table, gantry, and collimator calibration procedures. This potential for data entry error could affect the accuracy of the calibration process.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
- Manufacturer
- Elekta, Inc.
- Affected units
- 300
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)
- Model 3.0
Distribution
Part of a larger recall action
This product is one of 3 recalled by Elekta, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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