FDA Medical Device Recalls (openFDA)
Elekta, Inc.: MLCi/MCLi2. Radiation therapy.
- Recall number
- Z-1651-2012
- Recalling firm
- Elekta, Inc.
- Product
- MLCi/MCLi2. Radiation therapy.
- Status
- Terminated
- Initiated
- 2012-04-19
- Posted
- 2012-05-23
- Terminated
- 2014-10-06
- Reason
- The Y2 diaphragm block was found loose.
- Root cause
- Nonconforming Material/Component
- Action
- Elekta sent an "IMPORTANT FIELD SAFETY NOTICE" dated April 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to carry out the recommended weekly physics check of the X-ray and light field size calibration. If an error is found, customers are instructed to contact their local Elekta service engineer.
- Quantity
- 386
- Distribution
- Nationwide Distribution including Puerto Rico.
- Lot, serial or model codes
- MRT 2424/MRT 14401
- 510(k) numbers
- ["K082122"]
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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