Mevion Medical Systems, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0409-2017)

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

Product Classification:

Class II

Date Initiated: October 31, 2016

Date Posted: November 23, 2016

Recall Number: Z-0409-2017

Event ID: 75496

Reason for Recall:

Completing Setup Without Program Move Complete Can Cause An Isocenter Error

Status: Terminated

Product Quantity: 6 units

Code Information:

Serial NUmbers: S250-0001 through S250-0006

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated