Elekta Digital Accelerators Recalled for Default Value Reset Issues
Elekta, Inc. is recalling 472 digital accelerators because customers are resetting default values outside recommended factory settings.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a moderate risk. The source text describes a configuration issue without reporting specific injuries or illnesses, aligning with the criteria for a moderate severity score.
Plain-English summary
Elekta, Inc. is recalling 472 units of digital accelerators equipped with electrons and beam modulators, MLCi/MLCi2, Agility, or Asymmetric Heads. These devices are used to deliver radiation to defined target volumes.
The recall was initiated because customers are resetting the default values outside of recommended factory settings. This deviation from standard configurations may affect the device's performance.
The affected units were distributed nationwide in the United States, including all 50 states, the District of Columbia, and Puerto Rico. Consumers and healthcare facilities should contact Elekta, Inc. for further instructions regarding the recall.
The recalled product
- Product
- All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
- Manufacturer
- Elekta, Inc.
- Hazard
- Affected units
- 472
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 (20)
- 151855
- 151587
- 152246
- 151694
- 152019
- 105864
- 151729
- 105932
- 151574
- 152397
- 152559
- 152248
- 151875
- 153036
- 153072
- 151965
- 151076
- 151363
- 152448
- 105782
Distribution
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