FDA Medical Device Recalls (openFDA)
Elekta, Inc.: Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.
- Recall number
- Z-2581-2014
- Recalling firm
- Elekta, Inc.
- Product
- Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.
- Status
- Terminated
- Initiated
- 2014-08-18
- Posted
- 2014-09-04
- Terminated
- 2021-09-15
- Reason
- Incorrect Delivery of Composite VMAT Fields - When DICOM is exporting an arc plan (VMAT, Dynamic Conformal or 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.
- Root cause
- Software design
- Action
- The firm, Elekta, issued an "URGENT IMPORTANT FIELD SAFETY NOTICE (IFSN 382-01-MON-001)" to all affected customers on August 18, 2014. The notice describes the product, problems and actions taken. Confirmation of receipt is to be completed by October 31, 2014. The problem will be resolved in patches to the following releases - Monaco 3.30 and Monaco 5.00. Development is underway with a release date of September 2014 with confirmation of installation of the patch no later than 6 months from release of the patch. An updated notice from the manufacturer is also being sent to affected customers (FCO: 382-01-MON-001 VID:2.0). If you have any queries about this Notice, please contact your local Elekta office or call 770-300-9725 or email: Elekta_Global_PMS@elekta.com.
- Quantity
- 928 units
- Distribution
- Worldwide distribution: US (nationwide) including states of: AL, AK, AZ, CA, CO, CT, FL, IL, IN, MD, MA, MI, MN, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI, Puerto Rico; and countries of: Algeria, Angola, Antigua & Barbuda, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sir Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Ukraine.
- Lot, serial or model codes
- Versions 3.20.00 and higher
- 510(k) numbers
- ["K132971"]
- 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