FDA Medical Device Recalls (openFDA)
Elekta, Inc.: Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Recall number
- Z-0112-2016
- Recalling firm
- Elekta, Inc.
- Product
- Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Status
- Terminated
- Initiated
- 2015-09-15
- Posted
- 2015-10-07
- Terminated
- 2017-04-04
- Reason
- Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.
- Root cause
- Device Design
- Action
- The firm issued an URGENT IMPORTANT FIELD SAFETY NOTICE on 09/15/2015. The letter identified the affected device, as well as the reason for the recall, and clinical impact. Customers were informed that both issues would be resolved in Monaco Patch Release 5.10.01. The attached acknowledgement form should be completed, signed, and returned to a local Elekta Office or representative within 30 days. Questions regarding the notice should be directed to a local Elekta office.
- Quantity
- 154 units
- Distribution
- Worldwide Distribution -- US, including the states of CA, IN, MI, MO, TX and WI; and, the countries of Australia, Canada, Germany, Greece, India, Netherlands, New Zealand, Turkey, and the UK.
- Lot, serial or model codes
- Software Version 5.10.00
- 510(k) numbers
- ["K151233"]
- 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