FDA Medical Device Recalls (openFDA)
Mevion Medical Systems, Inc.: MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
- Recall number
- Z-1122-2017
- Recalling firm
- Mevion Medical Systems, Inc.
- Product
- MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
- Status
- Terminated
- Initiated
- 2016-12-16
- Posted
- 2017-02-02
- Terminated
- 2017-04-13
- Reason
- An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened
- Root cause
- Software design
- Action
- Mevion sent an Important Safety Notice to customers on 12/16/16 by email and Salesforce. The letter identified the affected product, problem and actions to be taken. Mevion provided mitigation and will release and install a software patch that removes the possibility that Deltas can be lost between multiple Setup fields. For further information contact rcessac@mevion.com.
- Quantity
- 2 units
- Distribution
- US Nationwide in the states of OK, NJ
- Lot, serial or model codes
- S250-0002 and S250-0003
- 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