MEVION S250 Radiation therapy system recall
MEVION S250 Radiation therapy system
Why was MEVION S250 Radiation therapy system recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Manufacturing Lot or Serial Number: S250-0004
- Product
- MEVION S250 Radiation therapy system
- Recalling firm
- Mevion Medical Systems, Inc.
- Quantity
- 4
- Distribution
- US nationwide distribution including FL, NJ, OK, and MO.
- Recall date
- February 17, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)