MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
FDA Recall #Z-1122-2017 — Class II — December 16, 2016
Product Description
MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Reason for Recall
An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened
Recalling Firm
Mevion Medical Systems, Inc. — Littleton, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2 units
Distribution
US Nationwide in the states of OK, NJ
Code Information
S250-0002 and S250-0003
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated