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Terminated

MEVION S250i

FDA Recall Z-0705-2019 · Posted None

Recalling FirmMevion Medical Systems, Inc.
Recall StatusTerminated
Product CodeLHN
Date Initiated2018-10-01
Date Terminated2020-04-10
Product Quantity1 unit

Reason for Recall

Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped

Firm Action

On-site Mevion Field Service Engineer communicated with the firm and is in daily communication with the single affected consignee.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

DC

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172848MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems · 2017-12-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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