Recall Z-1529-2016— Mevion Medical Systems, Inc.

Name: FDA recall Z-1529-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-15

Class II · Terminated

Class II FDA medical device recall by Mevion Medical Systems, Inc., initiated 2016-03-15, terminated 2017-08-24. It names one FDA 510(k) clearance: K120676. Product: MEVION S250 for Proton Radiation Therapy. Reason: 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..

Recalling firm: Mevion Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-03-15
Terminated: 2017-08-24
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 for Proton Radiation Therapy

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.

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