Elekta Agility Multileaf Collimator Recall for Missing Compatibility Information
Elekta is recalling two Agility Multileaf Collimators because the original product information did not specify compatibility with the Dynamic Multileaf Collimator Apex add-on.
What this means for you
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 temporary or medically reversible adverse health consequence. The specific hazard is a documentation error (missing compatibility information) rather than a direct physical defect causing injury, fitting the 'Moderate' criteria for labeling/documentation issues.
Plain-English summary
Elekta, Inc. is recalling two units of the Agility Multileaf Collimator. This medical device is used to deliver static and/or dynamic beams of radiation for single or multiple fractions in all areas of the body where such treatment is indicated.
The recall was initiated because the information released with the Agility product did not originally contain information regarding its compatibility with the add-on Dynamic Multileaf Collimator Apex. The affected units are identified by codes 152599 and 152678.
The recall covers a nationwide distribution, including the District of Columbia and Maryland. Users of the Agility Multileaf Collimator should verify the compatibility of their specific units with the Dynamic Multileaf Collimator Apex before use, as the original documentation did not provide this critical technical information.
The recalled product
- Product
- Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
- Manufacturer
- Elekta, Inc.
- Affected units
- 2
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)
- 152599 and 152678
Distribution
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