FDA Medical Device Recalls (openFDA)
Elekta, Inc.: Monaco RTP System Radiation treatment planning
- Recall number
- Z-2276-2013
- Recalling firm
- Elekta, Inc.
- Product
- Monaco RTP System Radiation treatment planning
- Status
- Terminated
- Initiated
- 2013-07-02
- Posted
- 2013-09-25
- Terminated
- 2014-05-08
- Reason
- Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.
- Root cause
- Device Design
- Action
- Monaco 3.3 upgrades have been temporarily halted and Important Safety Notice (LINMON0007) has been issued to effected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that couch files are checked for releases 3.20.00 and 3.30.00 to verify that the correct relative electron density values are being used in the dose calculation. If customers have edited the sample couch files, and previously upgraded to Monaco 3.20.00 or 3.30.00, their couch files have already been overwritten. Open the couch files, make the necessary updates to the couch parameters, and use the "Save As Treatment Couch" option to save the modified sample couch files to a new, unique name. Please note that the couch files can also be edited in Focal and then the patients opened in Monaco. Comparable Focal releases would be Focal4.64.00(Monaco 3.10.00), Focal4.70.00(Monaco 3.20.00) and Focal4.80.00 (Monaco 3.30.00). For questions regarding this recall call 404-993-5886.
- Quantity
- 45
- Distribution
- Nationwide Distribution including AK, CA, CO, CT, FL, IL, IN, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, WA and Puerto Rico.
- Lot, serial or model codes
- Versions 3.10.00 and later
- 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