Mevion Medical Systems, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0827-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)

Product Classification:

Class II

Date Initiated: February 1, 2022

Date Posted: April 6, 2022

Recall Number: Z-0827-2022

Event ID: 89758

Reason for Recall:

Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room.

Status: Ongoing

Product Quantity: 39 (36 US, 3 OUS)

Code Information:

All theryapy systems, all hand pendant serial numbers. Therapy system UDI 00864366000100 and UDI 00864366000124.

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated