FDA Medical Device Recalls (openFDA)
Elekta Inc: Monaco Radiation Treatment Planning System (RTP) System
- Recall number
- Z-0670-2020
- Recalling firm
- Elekta Inc
- Product
- Monaco Radiation Treatment Planning System (RTP) System
- Status
- Open, Classified
- Initiated
- 2019-11-22
- Posted
- not on file
- Terminated
- not on file
- Reason
- Monaco is using the incorrect energy when optimizing and calculating dose.
- Root cause
- Software Design Change
- Action
- An Important Field Safety Notification letter is being emailed to affected customers beginning 11/22/2019. The letter identifies affected product, provides a description of the problem, and recommends user not use multiple energies within the same plan until a software fix has been applied to the device. A response form was asked to be returned. Affected customers are advised to contact local Elekta service teams for questions.
- Quantity
- 76 (7 US, 69 OUS)
- Distribution
- IA, IN, NY, OH, TX, WI. Internationally distributed to: Australia, Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, Switzerland, United Kingdom.
- Lot, serial or model codes
- Software Builds: 5.40.00, 5.50.00 and 5.51.00. UDI GTIN: (01)00858164002190(10) 5.40.00, (01)00858164002244(10) 5.50.00, and (01)00858164002268(10) 5.51.00
- 510(k) numbers
- ["K183037","K190178"]
- 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