MEVION S250 for Proton Radiation Therapy recall
MEVION S250 for Proton Radiation Therapy
Why was MEVION S250 for Proton Radiation Therapy recalled?
Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and cause traumatic injury or death.
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?
S250-0002
- Product
- MEVION S250 for Proton Radiation Therapy
- Recalling firm
- Mevion Medical Systems, Inc.
- Quantity
- 5
- Distribution
- US nationwide distribution to MO, OK, FL, and NJ.
- Recall date
- April 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)