Z-0410-2017 Class II Terminated

Recalled by Mevion Medical Systems, Inc. — Littleton, MA

Recall Details

Product Type
Devices
Report Date
November 23, 2016
Initiation Date
October 21, 2016
Termination Date
May 10, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 units

Product Description

MEVION S250 Product Usage: Proton Radiation Therapy System

Reason for Recall

Recovery of Incorrect Isocenter -operational change

Distribution Pattern

US Nationwide Distribution in the states of FL, MO, NJ, OH and OK,

Code Information

Serial Number: S250-0001 through S250-0006