FDA Medical Device Recalls (openFDA)
Elekta Inc: Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
- Recall number
- Z-1825-2020
- Recalling firm
- Elekta Inc
- Product
- Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
- Status
- Open, Classified
- Initiated
- 2020-04-16
- Posted
- not on file
- Terminated
- not on file
- Reason
- The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.
- Root cause
- Software design
- Action
- In April of 2020, Elekta Inc. prepared an Urgent/Important Field Safety Notice identifying this issue, the actions that should be taken by the user/customer in order to prevent risks for patients and/or users, and the actions planned by Elekta to correct the problem. PRODUCT: The Monaco RTP System with versions 5.40 or 5.40.01 installed in or after June of 2018. ACTIONS TO BE TAKEN BY THE CUSTOMER OR USER: Customers/users are instructed to follow their standard clinical practice of reviewing plans, including the review of contours and volumes. DVHs that show unexpected overdose or under-dose should be investigated by the customer/user. The customer/user should post the issued notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed and to advise the appropriate personnel who are working with this product on the content of this letter. Customers/users are also required to either acknowledge receipt of this notification via the Elekta Care Community or complete the provided acknowledgement form and return it to Elekta immediately upon receipt, but no later than within 30 days of receiving the notification letter.
- Quantity
- 96 devices
- Distribution
- Worldwide distribution - US Nationwide Distribution in the states of IA, NJ, NY, PA, TX, WI and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, United Kingdom.
- Lot, serial or model codes
- Software Build: 5.40.00 (UDI: (01)00858164002190(10) 5.40.00), 5.40.01 (UDI: 01)00858164002190(10) 5.40.01)
- 510(k) numbers
- ["K183037"]
- PMA numbers
- not on file
- Product code
- MUJ
- Firm FEI
- 1937649
- Firm city
- Saint Charles
- 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