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 Radiation therapy system

FDA Recall Z-0767-2016 · Posted 2016-02-08

Recalling FirmMevion Medical Systems, Inc.
Recall StatusTerminated
Product CodeLHN
Date Initiated2015-11-18
Date Terminated2017-04-03
Product Quantity4

Reason for Recall

The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.

Firm Action

Customer notification letter was sent via certified mail on November 18, 2015. The notification explains the issue and actions to be taken by the customer.

Root Cause

Labeling design

Distribution Pattern

US nationwide distribution including FL, NJ, OK, and MO.

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.

↑