FDA Medical Device Recalls (openFDA)
Elekta, Inc.: DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
- Recall number
- Z-0978-2014
- Recalling firm
- Elekta, Inc.
- Product
- DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
- Status
- Terminated
- Initiated
- 2013-05-01
- Posted
- 2014-02-25
- Terminated
- 2015-01-29
- Reason
- It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
- Root cause
- Component design/selection
- Action
- Elekta sent an Important Field Safety Notice letter dated May 2013 to affected customers. The letter identified the scope, problem, clinical impact, solution, and safety reference. For question call +44 (0)1293 544422
- Quantity
- 35 units
- Distribution
- US Nationwide Distribution in the states of CT, FL, GA, IA, MO, NY, ND, OK, RI, TX, VA, WA
- Lot, serial or model codes
- Identifier : 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116063, 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