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Terminated

MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients

FDA Recall Z-2686-2020 · Posted None

Recalling FirmMevion Medical Systems, Inc.
Recall StatusTerminated
Product CodeLHO
Date Initiated2020-06-23
Date Terminated2020-12-09
Product Quantity8 units

Reason for Recall

The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.

Firm Action

This screen would not be accessed by normal user (only servicer). Firm is notifying servicing personnel and not consumer/user level. No customer letters/communication sent. Servicer will install edge guard on effected units. Technical Service Bulletin issued to servicer.

Root Cause

Device Design

Distribution Pattern

MO, NJ, OK, FL, OH, DC, Netherlands

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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