Mevion Medical Systems, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1529-2016)

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 for Proton Radiation Therapy

Product Classification:

Class II

Date Initiated: March 15, 2016

Date Posted: April 27, 2016

Recall Number: Z-1529-2016

Event ID: 73602

Reason for Recall:

Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and cause traumatic injury or death.

Status: Terminated

Product Quantity: 5

Code Information:

S250-0002

Distribution Pattern:

US nationwide distribution to MO, OK, FL, and NJ.

Voluntary or Mandated:

Voluntary: Firm initiated