FDA Medical Device Recalls (openFDA)
Elekta, Inc.: Desktop Pro R6.0 & R6.1, Linear Medical Accelerator.
- Recall number
- Z-0421-2007
- Recalling firm
- Elekta, Inc.
- Product
- Desktop Pro R6.0 & R6.1, Linear Medical Accelerator.
- Status
- Terminated
- Initiated
- 2006-11-23
- Posted
- 2007-02-07
- Terminated
- 2008-05-14
- Reason
- Unexpected Diaphragm movement when manual field size modifications are not saved.
- Root cause
- Software design
- Action
- Consignees were notified by letter on/about 11/23/2006
- Quantity
- 37 units
- Distribution
- Worldwide distribution ---- including USA states of AZ, AL, CA, CO, FL, GA, IA, MI, NV, OH, OK, PA, WA, WV and Country of Canada .
- Lot, serial or model codes
- Model number MRT 9871/ MRT 10601 (This issue affects Desktop Pro 6.0 and 6.1 users with a 3rd party R & V System, with the exception of Sigma Micro Users)
- 510(k) numbers
- ["K982713"]
- 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