Mevion Medical Systems, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0588-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

MEVION S250, used for proton radiation therapy.

Product Classification:

Class II

Date Initiated: November 10, 2014

Date Posted: December 17, 2014

Recall Number: Z-0588-2015

Event ID: 69778

Reason for Recall:

Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.

Status: Terminated

Product Quantity: 1

Code Information:

Serial Number: S250-0001

Distribution Pattern:

US Distribution in the state of MO

Voluntary or Mandated:

Voluntary: Firm initiated