FDA Medical Device Recalls (openFDA)
Mevion Medical Systems, Inc.: Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
- Recall number
- Z-0827-2022
- Recalling firm
- Mevion Medical Systems, Inc.
- Product
- Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
- Status
- Open, Classified
- Initiated
- 2022-02-01
- Posted
- not on file
- Terminated
- not on file
- Reason
- Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room.
- Root cause
- Component design/selection
- Action
- Mevion has voluntarily recalled Hand Pendants for S250 and S250i Proton Therapy Systems. All distributed Hand Pendants have been inspected for the identified defect and those that failed inspection have been removed from service following technical service bulletin TSB0048. Subsequent Urgent Medical Device Recall Notice dated 02/11/2022 was hand delivered by on-site field service engineers. Customers are instructed to complete and return the acknowledgement receipt. Please contact Mevion Customer service (robyn.walker@mevion.com) with any questions or concerns.
- Quantity
- 39 (36 US, 3 OUS)
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands.
- Lot, serial or model codes
- All theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124.
- 510(k) numbers
- ["K120676","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