FDA Medical Device Recalls (openFDA)
Mevion Medical Systems, Inc.: MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
- Recall number
- Z-1271-2014
- Recalling firm
- Mevion Medical Systems, Inc.
- Product
- MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
- Status
- Terminated
- Initiated
- 2014-03-05
- Posted
- 2014-03-22
- Terminated
- 2014-04-03
- Reason
- Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields
- Root cause
- Software design
- Action
- Mervion issued an Important Safety Notice letter on March 5, 2014 by visit to sites to the single customer using the product to prevent the use of multiple isocenters treatment modalities. The letter identified the affected product, problem and actions to be taken. For questions call 978-540-1555.
- Quantity
- 1 unit
- Distribution
- USA Nationwide Distribution in the state of MO
- Lot, serial or model codes
- 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