Mevion S250i recall
MEVION S250i, MEVION S250; Proton Radiation Treatment System
Why was Mevion S250i recalled?
Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off
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: 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 S250i, MEVION S250; Proton Radiation Treatment System
- Recalling firm
- Mevion Medical Systems, Inc.
- Quantity
- 8 units
- Distribution
- Distribution to US in MO, NJ, OH, OK, FL, and DC, and the Netherlands
- Recall date
- July 1, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)