FDA Medical Device Recalls (openFDA)
Elekta, Inc.: Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.
- Recall number
- Z-0014-2012
- Recalling firm
- Elekta, Inc.
- Product
- Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.
- Status
- Terminated
- Initiated
- 2011-05-25
- Posted
- not on file
- Terminated
- 2014-01-14
- Reason
- It is possible to load different patients in the record and verify (R&V) system and in the multilead control software (MCS).
- Root cause
- Device Design
- Action
- Elekta, Inc. sent an "IMPORTANT NOTICE" letter dated May 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter recommends several precautions customers should use until Elekta finds a solution. Customers will be contacted when a solution is found.
- Quantity
- 27
- Distribution
- Nationwide Distribution-USA including the state of CT, FL, GA, IA, MN, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA , and WA.
- Lot, serial or model codes
- 116001, 116012, 116044, EM7-008, 116055, 116064, 116014, 116052, 116023, 116056, 116053, 116047, 116043, 116051, 116070, 116122, 116063, 116020, EM7-003, EM-029, EM7-006, 116024, 116068, 116013, EM3-026, EM3-004, 116046
- 510(k) numbers
- ["K001163"]
- PMA numbers
- not on file
- Product code
- MUJ
- 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