FDA Medical Device Recalls (openFDA)
Elekta, Inc.: 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.
- Recall number
- Z-2340-2012
- Recalling firm
- Elekta, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2012-07-27
- Posted
- 2012-09-10
- Terminated
- 2014-10-06
- Reason
- Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.
- Root cause
- Error in labeling
- Action
- ELEKTA sent an Important Field Safety Notice, FCO Ref: 20001405000 dated July 7, 2012, to current Agility users and a separate notice FCO Ref: 20001407026 for current Apex users who may be in the process of considering an upgrade to Agility. Both notices made it clear that Apex has not been integrated or classified as compatible for use with Agility. Users are advised not to use Apex with Agility. For questions regarding this recall call 770-300-9725.
- Quantity
- 2
- Distribution
- Nationwide Distribution including DC & MD
- Lot, serial or model codes
- 152599 and 152678
- 510(k) numbers
- ["K121328"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 1037831
- Firm city
- Norcross
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28