MEVION S250 Product Usage: Proton Radiation Therapy recall: Software Issue
MEVION S250 Product Usage: Proton Radiation Therapy System
Why was MEVION S250 Product Usage: Proton Radiation Therapy recalled?
Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter
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?
Serial Numbers: S250-0001 through S250-0006
- Product
- MEVION S250 Product Usage: Proton Radiation Therapy System
- Recalling firm
- Mevion Medical Systems, Inc.
- Quantity
- 6 units
- Distribution
- US Nationwide Distribution in the states of: FL, MO, NJ, OH, OK
- Recall date
- November 23, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)