FDA Medical Device Recalls (openFDA)
Mevion Medical Systems, Inc.: MEVION S250 Product Usage: Proton Radiation Therapy
- Recall number
- Z-0409-2017
- Recalling firm
- Mevion Medical Systems, Inc.
- Product
- MEVION S250 Product Usage: Proton Radiation Therapy
- Status
- Terminated
- Initiated
- 2016-10-31
- Posted
- 2016-11-15
- Terminated
- 2017-06-29
- Reason
- Completing Setup Without Program Move Complete Can Cause An Isocenter Error
- Root cause
- Software design
- Action
- Mevion issued an Important Safety Notice letter on October 31, 2016 to customers. The identified the affected product, problem, mitigation and advisory information. The letter informed customers that Mevion will release and install a software patch that removes the reliance on tracking isocenter changes for the correct reporting of the Couch position to the user displays and to the OIS. For further information mailto:srosenthal@mevion.com
- Quantity
- 6 units
- Distribution
- US Nationwide in the states of FL, MO, NJ and OK
- Lot, serial or model codes
- Serial NUmbers: S250-0001 through S250-0006
- 510(k) numbers
- ["K120676"]
- PMA numbers
- not on file
- Product code
- MUJ
- Firm FEI
- 3007087027
- Firm city
- Littleton
- Firm state
- MA
- 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