FDA Medical Device Recalls (openFDA)
Mevion Medical Systems, Inc.: MEVION S250 Product Usage: Proton Radiation Therapy System
- Recall number
- Z-0410-2017
- Recalling firm
- Mevion Medical Systems, Inc.
- Product
- MEVION S250 Product Usage: Proton Radiation Therapy System
- Status
- Terminated
- Initiated
- 2016-10-21
- Posted
- 2016-11-15
- Terminated
- 2017-05-10
- Reason
- Recovery of Incorrect Isocenter -operational change
- Root cause
- Software Design Change
- Action
- Mevion issued an User Notice letter on October 24, 2016 to their customers. The letter identified the affected product, problem and actions taken. Customers were informed that Mevion will be updating software when it is released. For further clarification or assistance, please contact Rob Cessac by email at rcessac@mevion.com or by phone at (978) 540-1501.
- Quantity
- 6 units
- Distribution
- US Nationwide Distribution in the states of FL, MO, NJ, OH and OK,
- Lot, serial or model codes
- Serial Number: 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