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Terminated

MEVION S250, used for proton radiation therapy.

FDA Recall Z-0588-2015 · Posted 2014-12-12

Recalling FirmMevion Medical Systems, Inc.
Recall StatusTerminated
Product CodeLHN
Date Initiated2014-11-10
Date Terminated2015-03-18
Product Quantity1

Reason for Recall

Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.

Firm Action

Mevion Medical Systems sent an Important Safety Notice letter to the affected customer. The letter identified the affected product, problem and actions to be taken. A software update addressing the issue will be provided to the customer on or about December 5, 2014. For questions or concerns, email [email protected] or call 978-540-1555.

Root Cause

Software design

Distribution Pattern

US 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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