Mevion Medical Systems, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0410-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

MEVION S250 Product Usage: Proton Radiation Therapy System

Product Classification:

Class II

Date Initiated: October 21, 2016

Date Posted: November 23, 2016

Recall Number: Z-0410-2017

Event ID: 75498

Reason for Recall:

Recovery of Incorrect Isocenter -operational change

Status: Terminated

Product Quantity: 6 units

Code Information:

Serial Number: S250-0001 through S250-0006

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated