FDA Medical Device Recalls (openFDA)
Elekta, Inc.: Monaco Radiation Treatment Planning (RTP) System
- Recall number
- Z-0965-2019
- Recalling firm
- Elekta, Inc.
- Product
- Monaco Radiation Treatment Planning (RTP) System
- Status
- Terminated
- Initiated
- 2019-02-08
- Posted
- not on file
- Terminated
- 2024-08-19
- Reason
- If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.
- Root cause
- Software design
- Action
- Elekta notified customers on about 2/08/2019 via "URGENT IMPORTANT FIELD SAFETY NOTIFICATION." Instructions included to ensure the optimization model is set to "Reproduce Goal Dose" when creating a completion plan. Customers were also requested to post the recall notice in an accessible place for all users to see, advise the appropriate personnel working with the device of the recall, and to complete and return the Acknowledgement Form. The issue will be resolved in Monaco release 5.40.01.
- Quantity
- 14 devices
- Distribution
- Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.
- Lot, serial or model codes
- Software version 5.40
- 510(k) numbers
- ["K183037"]
- 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