Elekta Agility software recall for potential calibration input errors
Elekta is recalling Agility software version 3.1 for linear accelerators because incorrect values could 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 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 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators associated with Agility collimators. The recall involves 134 units distributed worldwide, including the United States, DC, Puerto Rico, and numerous international countries.
The recall is due to a software issue where it is possible to type incorrect values or invert a value during the treatment table, gantry, and collimator calibration procedures. This potential for data entry errors could affect the accuracy of the calibration process.
Healthcare facilities and users of the affected software should contact Elekta, Inc. for further instructions on how to address the issue. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- Agility. Version 3.1 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
- 134
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 3.1
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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