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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75494

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 20, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mevion Medical Systems, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

MEVION S250 Product Usage: Proton Radiation Therapy System

Z-0411-2017
Recall number
Z-0411-2017
Initiated
October 20, 2016
Classification
Class II
Status
Terminated
Quantity
6 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect:2D projection of contours in Verity. The defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter

Code information

Serial Numbers: S250-0001 through S250-0006

Distribution pattern

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