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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69778

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

Open FDA event record

Event summary

Timeline bucket
November 10, 2014
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, used for proton radiation therapy.

Z-0588-2015
Recall number
Z-0588-2015
Initiated
November 10, 2014
Classification
Class II
Status
Terminated
Quantity
1

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect that causes an incorrect

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 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%.

Code information

Serial Number: S250-0001

Distribution pattern

US Distribution in the state of MO