FDA Medical Device Recalls (openFDA)
Elekta, Inc.: Monaco Product Usage: Planning of radiation therapy
- Recall number
- Z-2007-2012
- Recalling firm
- Elekta, Inc.
- Product
- Monaco Product Usage: Planning of radiation therapy
- Status
- Terminated
- Initiated
- 2012-06-21
- Posted
- 2012-07-12
- Terminated
- 2014-04-01
- Reason
- Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
- Root cause
- Software design
- Action
- Elekta sent an Important Safety Notice to affected customers. The notice identified the affected product, problem, clinical impact and actions to be taken. The notice inform customers of how the issue will be resolved and instructions to follow when it is available.
- Quantity
- 38
- Distribution
- US Nationwide Distribution - including the states of: CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI
- Lot, serial or model codes
- Version 3.10.00 - 3.20.00, inclusive
- 510(k) numbers
- ["K110730"]
- 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