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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67958

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

Open FDA event record

Event summary

Timeline bucket
June 29, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Fujifilm Medical System USA, 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

MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator

Z-1642-2014
Recall number
Z-1642-2014
Initiated
June 29, 2012
Classification
Class II
Status
Terminated
Quantity
14

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2.

Code information

SN: MXA1170108, MXA1270262

Distribution pattern

Worldwide Distribution - US Distribution including the states of TX and KY and Internationally to China.