Mevion S250 Radiation Therapy System Recalled for Positioning Belt Slippage
Mevion Medical Systems is recalling four MEVION S250 Radiation Therapy Systems because the treatment table positioning belt can slip, causing patient setup deviations.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, an FDA Class II recall involving a structural defect that leads to significant injury or property damage reports (or significant risk thereof) is rated as Severe (4).
Plain-English summary
Mevion Medical Systems, Inc. is recalling four MEVION S250 Radiation Therapy Systems. The recall is due to a defect in the treatment table positioning belt, which can slip gear positions. This slippage results in a deviation of patient setup and treatment positions from the time the slippage occurs until it is discovered and treatment is halted.
The affected units were distributed nationwide in the United States, including Florida, New Jersey, Oklahoma, and Missouri. The specific unit identified in the recall notice has the Manufacturing Lot or Serial Number S250-0004.
Healthcare facilities using these systems should contact Mevion Medical Systems for instructions on halting treatment and addressing the defect to ensure patient safety.
The recalled product
- Product
- MEVION S250 Radiation therapy system
- Manufacturer
- Mevion Medical Systems, Inc.
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Manufacturing Lot or Serial Number: S250-0004
Distribution
Related recalls
Same manufacturer · Mevion Medical Systems, Inc.
See all →- HighHand Pendant Malfunction in Proton Therapy Systems Poses Patient Injury Risk
FDA (Devices) · 2022-04-06
- HighMevion Proton Radiation Treatment System Recalled for Screen Display Failure
FDA (Devices) · 2020-12-02
- HighMevion S250 Proton Radiation System Recalled for Sharp Edge Hazard
FDA (Devices) · 2020-07-29
- HighMevion Proton Radiation Treatment System Recalled for Software Error
FDA (Devices) · 2020-07-01
- ModerateMevion Medical Systems Recalls MEVION S250i Medical Device
FDA (Devices) · 2019-01-16
Same hazard · mechanical failure
See all →- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28