Recall Z-2686-2020— Mevion Medical Systems, Inc.

Name: FDA recall Z-2686-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-23

Class II · Terminated

Class II FDA medical device recall by Mevion Medical Systems, Inc., initiated 2020-06-23, terminated 2020-12-09. It names one FDA 510(k) clearance: K120676. Product: MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients. Reason: The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer..

Recalling firm: Mevion Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-06-23
Terminated: 2020-12-09
Firm location: Littleton, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K120676 — S-250 PROTON BEAM RADIATION THERAPY SYSTEMMevion Medical Systems·cleared 2012-06-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients

Reason for recall

The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.

Data sourced from openFDA. This site is unofficial and independent of the FDA.