FDA Medical Device Recalls (openFDA)
Mevion Medical Systems, Inc.: MEVION S250, used for proton radiation therapy.
- Recall number
- Z-0588-2015
- Recalling firm
- Mevion Medical Systems, Inc.
- Product
- MEVION S250, used for proton radiation therapy.
- Status
- Terminated
- Initiated
- 2014-11-10
- Posted
- 2014-12-12
- Terminated
- 2015-03-18
- Reason
- Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.
- Root cause
- Software design
- Action
- Mevion Medical Systems sent an Important Safety Notice letter to the affected customer. The letter identified the affected product, problem and actions to be taken. A software update addressing the issue will be provided to the customer on or about December 5, 2014. For questions or concerns, email lbouchet@mevion.com or call 978-540-1555.
- Quantity
- 1
- Distribution
- US Distribution in the state of MO
- Lot, serial or model codes
- Serial Number: S250-0001
- 510(k) numbers
- ["K120676"]
- PMA numbers
- not on file
- Product code
- LHN
- 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