Recall Z-0588-2015— Mevion Medical Systems, Inc.

Name: FDA recall Z-0588-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-10

Class II · Terminated

Class II FDA medical device recall by Mevion Medical Systems, Inc., initiated 2014-11-10, terminated 2015-03-18. It names one FDA 510(k) clearance: K120676. Product: MEVION S250, used for proton radiation therapy.. Reason: Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%..

Recalling firm: Mevion Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-11-10
Terminated: 2015-03-18
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, used for proton radiation therapy.

Reason for recall

Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.

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