FDA Medical Device Recalls (openFDA)
Elekta, Inc.: Monaco RTP System. Radiation treatment planning.
- Recall number
- Z-0841-2013
- Recalling firm
- Elekta, Inc.
- Product
- Monaco RTP System. Radiation treatment planning.
- Status
- Terminated
- Initiated
- 2013-02-11
- Posted
- 2013-02-20
- Terminated
- 2014-01-21
- Reason
- The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
- Root cause
- Nonconforming Material/Component
- Action
- Elekta provided customers with an "Important Safety Notice - Dose Display Not Matching Beam Geometry - Monaco RFC 35748". The notice identified the product, problem, and actions to be taken by the customers. Contact the form at 800-878-4267 for questions relating to this notice.
- Quantity
- 13
- Distribution
- Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.
- Lot, serial or model codes
- Versions 3.20.00 and 3.20.01
- 510(k) numbers
- ["K110730"]
- PMA numbers
- not on file
- Product code
- MUJ
- 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