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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
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