Mevion Medical Systems, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2746-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.

Product Classification:

Class II

Date Initiated: June 29, 2018

Date Posted: August 22, 2018

Recall Number: Z-2746-2018

Event ID: 80615

Reason for Recall:

QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged when used with incompatible (third-party) accessories. This can create unsafe conditions for use and may compromise the subsequent use of any kVue inserts, whether authorized or not. Use of unauthorized or unvalidated inserts may lead to an incorrect patient treatment or physical injury.

Status: Terminated

Product Quantity: 7

Code Information:

S250-0001 through S250-0006 and S250i-0007

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated