Recall Z-0411-2017— Mevion Medical Systems, Inc.

Name: FDA recall Z-0411-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-20

Class II · Terminated

Class II FDA medical device recall by Mevion Medical Systems, Inc., initiated 2016-10-20, terminated 2017-05-15. It names one FDA 510(k) clearance: K120676. Product: MEVION S250 Product Usage: Proton Radiation Therapy System. Reason: Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter.

Recalling firm: Mevion Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-10-20
Terminated: 2017-05-15
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

Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter

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