Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0411-2017 — MEVION S250 Product Usage: Proton Radiation Therapy System

U.S. FDA — Device Enforcement · United States · 2016-10-20 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0411-2017
Date of alert
2016-10-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Mevion Medical Systems, Inc.
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.