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Terminated

MEVION S250 Product Usage: Proton Radiation Therapy System

FDA Recall Z-0410-2017 · Posted 2016-11-15

Recalling FirmMevion Medical Systems, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2016-10-21
Date Terminated2017-05-10
Product Quantity6 units

Reason for Recall

Recovery of Incorrect Isocenter -operational change

Firm Action

Mevion issued an User Notice letter on October 24, 2016 to their customers. The letter identified the affected product, problem and actions taken. Customers were informed that Mevion will be updating software when it is released. For further clarification or assistance, please contact Rob Cessac by email at [email protected] or by phone at (978) 540-1501.

Root Cause

Software Design Change

Distribution Pattern

US Nationwide Distribution in the states of FL, MO, NJ, OH and OK,

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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