FDA Medical Device Recalls (openFDA)
Elekta, Inc.: DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
- Recall number
- Z-2157-2013
- Recalling firm
- Elekta, Inc.
- Product
- DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
- Status
- Terminated
- Initiated
- 2013-08-15
- Posted
- 2013-09-04
- Terminated
- 2015-07-28
- Reason
- Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.
- Root cause
- Device Design
- Action
- Important Field Safety Notices 200 01 406 030 (Changes to your system to improve the safe operation of DMLC) and 200 01 602 031 (Changes to your system to improve the safe operation of 3DLINE DMLC) letters were sent to customers on 8/15/2013 advising them of the issue and recommendations to resolve either by upgrading their system or to discontinue a clinical use of the device.
- Quantity
- 31
- Distribution
- Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico.
- Lot, serial or model codes
- EM-042, EM7-004, EM-046, EM-060, EM-047, EM-029, EM7-003, EM7-002, EM7-008, EM-062, EM-063, EM3-004, 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116068, 116013, 116046
- 510(k) numbers
- ["K001163"]
- PMA numbers
- not on file
- Product code
- IXI
- Firm FEI
- 1037831
- Firm city
- Atlanta
- 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