FDA Medical Device Recalls (openFDA)
Mevion Medical Systems, Inc.: MEVION S250 Radiation therapy system
- Recall number
- Z-0767-2016
- Recalling firm
- Mevion Medical Systems, Inc.
- Product
- MEVION S250 Radiation therapy system
- Status
- Terminated
- Initiated
- 2015-11-18
- Posted
- 2016-02-08
- Terminated
- 2017-04-03
- Reason
- The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.
- Root cause
- Labeling design
- Action
- Customer notification letter was sent via certified mail on November 18, 2015. The notification explains the issue and actions to be taken by the customer.
- Quantity
- 4
- Distribution
- US nationwide distribution including FL, NJ, OK, and MO.
- Lot, serial or model codes
- Manufacturing Lot or Serial Number: S250-0004
- 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