Mevion S250 and S250i Proton Therapy Systems hand pendant… recallZ-0827-2022 · Mevion Medical Systems, Inc. · initiated Feb 1, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mevion Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Component design/selection
What the company is doing
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 ([email protected]) with any questions or concerns.
Recall details
- Recall number
- Z-0827-2022
- Status
- Open, Classified
- Initiated by the company
- Feb 1, 2022
- Recalling firm
- Mevion Medical Systems, Inc.
- Quantity
- 39 (36 US, 3 OUS)
- Product code
- LHN
- FDA submissions
- K120676, K172848
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands.
Product description
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Code information (models, lots, serial numbers)
All theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- MEVION S250iMevion Medical Systems, Inc. · System, Radiation Therapy, Charged-Particle, Medical5 recalls5 reports
- Mevion Medical Systems S250Mevion Medical Systems, Inc. · System, Radiation Therapy, Charged-Particle, Medical4 recalls1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page