Recall Z-0705-2019— Mevion Medical Systems, Inc.

Name: FDA recall Z-0705-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-01

Class II · Terminated

Class II FDA medical device recall by Mevion Medical Systems, Inc., initiated 2018-10-01, terminated 2020-04-10. It names one FDA 510(k) clearance: K172848. Product: MEVION S250i. Reason: Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped.

Recalling firm: Mevion Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-10-01
Terminated: 2020-04-10
Firm location: Littleton, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K172848 — MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems·cleared 2017-12-27

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 S250i

Reason for recall

Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped

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