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Terminated

MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy

FDA Recall Z-1271-2014 · Posted 2014-03-22

Recalling FirmMevion Medical Systems, Inc.
Recall StatusTerminated
Product CodeLHN
Date Initiated2014-03-05
Date Terminated2014-04-03
Product Quantity1 unit

Reason for Recall

Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields

Firm Action

Mervion issued an Important Safety Notice letter on March 5, 2014 by visit to sites to the single customer using the product to prevent the use of multiple isocenters treatment modalities. The letter identified the affected product, problem and actions to be taken. For questions call 978-540-1555.

Root Cause

Software design

Distribution Pattern

USA Nationwide Distribution in the state of 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.

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