Mevion Medical Systems, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0411-2017)

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 20, 2016

Date Posted: November 23, 2016

Recall Number: Z-0411-2017

Event ID: 75494

Reason for Recall:

Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter

Status: Terminated

Product Quantity: 6 units

Code Information:

Serial Numbers: S250-0001 through S250-0006

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated