FDA Medical Device Recalls (openFDA)
Elekta, Inc.: Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
- Recall number
- Z-2277-2013
- Recalling firm
- Elekta, Inc.
- Product
- Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
- Status
- Terminated
- Initiated
- 2013-05-22
- Posted
- 2013-09-25
- Terminated
- 2013-12-23
- Reason
- Patient needs to be positioned as indicated by the treatment plan.
- Root cause
- Labeling design
- Action
- Computerized Medical Systems issued an Important Safety Notice dated May 22, 2013 to all affected customers. This letter idenitfies the problems the products and the actions needed to be takem by the custom.
- Quantity
- 72
- Distribution
- Distributed in Puerto Rico and the states of AK, AZ, CA, CO, CT, FL, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, and WA.
- Lot, serial or model codes
- All versions of Monaco
- 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