MEVION S250 Proton Radiation Treatment System recall
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Why was MEVION S250 Proton Radiation Treatment System recalled?
The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.
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?
Lot #s: MEVION S250-0001 MEVION S250-0002 MEVION S250-0003 MEVION S250-0004 MEVION S250-0005 MEVION S250-0006 MEVION S250-0007 MEVION S250-0008 UDI: (01)00864366000100 (11) 131209 (01)00864366000100 (11)150526 (01)00864366000100 (11)150113 (01)00864366000100 (11)150430 (01)00864366000100 (11)160127 (01)00864366000100 (11)160603 (01)00864366000124 (11) 180220 (01)00864366000124 (11) 181219
- Product
- MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
- Recalling firm
- Mevion Medical Systems, Inc.
- Quantity
- 8 units
- Distribution
- MO, NJ, OK, FL, OH, DC, Netherlands
- Recall date
- July 29, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)