Recall Z-0410-2017— Mevion Medical Systems, Inc.

Name: FDA recall Z-0410-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-21

Class II · Terminated

Class II FDA medical device recall by Mevion Medical Systems, Inc., initiated 2016-10-21, terminated 2017-05-10. It names one FDA 510(k) clearance: K120676. Product: MEVION S250 Product Usage: Proton Radiation Therapy System. Reason: Recovery of Incorrect Isocenter -operational change.

Recalling firm: Mevion Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-10-21
Terminated: 2017-05-10
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 Product Usage: Proton Radiation Therapy System

Reason for recall

Recovery of Incorrect Isocenter -operational change

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