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Terminated

MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy

FDA Recall Z-1122-2017 · Posted 2017-02-02

Recalling FirmMevion Medical Systems, Inc.
Recall StatusTerminated
Product CodeLHN
Date Initiated2016-12-16
Date Terminated2017-04-13
Product Quantity2 units

Reason for Recall

An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened

Firm Action

Mevion sent an Important Safety Notice to customers on 12/16/16 by email and Salesforce. The letter identified the affected product, problem and actions to be taken. Mevion provided mitigation and will release and install a software patch that removes the possibility that Deltas can be lost between multiple Setup fields. For further information contact [email protected].

Root Cause

Software design

Distribution Pattern

US Nationwide in the states of OK, NJ

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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