FDA Medical Device Recalls (openFDA)
Elekta, Inc.: Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Recall number
- Z-1009-2017
- Recalling firm
- Elekta, Inc.
- Product
- Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Status
- Terminated
- Initiated
- 2016-12-21
- Posted
- not on file
- Terminated
- 2021-07-16
- Reason
- Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
- Root cause
- Nonconforming Material/Component
- Action
- Elekta sent an Urgent Important Field Safety Notification letter dated December 2016 to customers. The notice informs users of the specific product and version numbers affected by the issue and any work arounds that can be used to avoid the issue. The notice included a reply form to be returned to Elekta.
- Quantity
- 279
- Distribution
- Worldwide Distribution - US Nationwide in the state of CA, IN, KY, MA, NJ, NY, NC, PA, TX, WI, and the countries of Brazil, Canada, China, Croatia, Estonia, Germany, India, Japan, Netherlands, New Zealand, Norway, Poland, Serbia, South Africa, Spain, Russia, Turkey
- Lot, serial or model codes
- Software Versions 5.00 and higher
- 510(k) numbers
- ["K132971","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