FDA Medical Device Recalls (openFDA)
Mevion Medical Systems, Inc.: MEVION S250i
- Recall number
- Z-0705-2019
- Recalling firm
- Mevion Medical Systems, Inc.
- Product
- MEVION S250i
- Status
- Terminated
- Initiated
- 2018-10-01
- Posted
- not on file
- Terminated
- 2020-04-10
- Reason
- Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped
- Root cause
- Software Manufacturing/Software Deployment
- Action
- On-site Mevion Field Service Engineer communicated with the firm and is in daily communication with the single affected consignee.
- Quantity
- 1 unit
- Distribution
- DC
- Lot, serial or model codes
- DI: (01)00864366000124 Serial Number: S250i-0007
- 510(k) numbers
- ["K172848"]
- 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