Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

MEVION S250 Product Usage: Proton Radiation Therapy System

FDA Recall Z-0411-2017 · Posted 2016-11-15

Recalling FirmMevion Medical Systems, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2016-10-20
Date Terminated2017-05-15
Product Quantity6 units

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

Firm Action

Mevion issued an Important Safety Notice letter on October 14, 2016 to their customers. The letter identified the affected product, problem, containment, mitigation and actions taken. Customers were informed that Mevion will be updating software when it is released. For further Information, contact: [email protected].

Root Cause

Software design

Distribution Pattern

US Nationwide Distribution in the states of: FL, MO, NJ, OH, OK

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120676S-250 PROTON BEAM RADIATION THERAPY SYSTEMMevion Medical Systems · 2012-06-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑