FDA Medical Device Recalls (openFDA)
Elekta Inc: Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
- Recall number
- Z-2091-2019
- Recalling firm
- Elekta Inc
- Product
- Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
- Status
- Open, Classified
- Initiated
- 2019-07-03
- Posted
- not on file
- Terminated
- not on file
- Reason
- When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.
- Root cause
- Under Investigation by firm
- Action
- Elekta began distribution of their Important Field Safety Notice to all affected customers from 07/03/2019 by email. The notice informs users of the specific product and version numbers affected by the issue, and any work-arounds that can be used to avoid the issue. The problem will be resolved in a future Monaco software release.
- Quantity
- 1396 units
- Distribution
- worldwide
- Lot, serial or model codes
- all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11
- 510(k) numbers
- ["K151233"]
- PMA numbers
- not on file
- Product code
- MUJ
- Firm FEI
- 1937649
- Firm city
- Maryland Heights
- Firm state
- MO
- 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