Recall Z-1271-2014— Mevion Medical Systems, Inc.

Name: FDA recall Z-1271-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-05

Class II · Terminated

Class II FDA medical device recall by Mevion Medical Systems, Inc., initiated 2014-03-05, terminated 2014-04-03. It names one FDA 510(k) clearance: K120676. Product: MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy. Reason: Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields.

Recalling firm: Mevion Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-03-05
Terminated: 2014-04-03
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, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy

Reason for recall

Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields

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