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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69939

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

Open FDA event record

Event summary

Timeline bucket
September 08, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Xoran Technologies, LLC

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

Xoran MiniCAT X-ray imaging device

Z-1210-2015
Recall number
Z-1210-2015
Initiated
September 08, 2014
Classification
Class II
Status
Terminated
Recalling firm
Xoran Technologies, LLC
Quantity
432

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.

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

Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.

Code information

S/N ENT00031 MiniCAT0020 MiniCAT00361 MiniCAT00358 MiniCAT00150 MiniCAT00310 ENT00006 ENT00055 ENT00059 MiniCAT00140 MiniCAT00305 ENT00014 MiniCAT00148 ENT00039 ENT00076 MiniCAT00409 MiniCAT00179 ENT00014 MiniCAT00215 MiniCAT00309 ENT00035 MiniCAT00158 MiniCAT00386 MiniCAT00202 MiniCAT00324 ENT00127 MiniCAT00352 MiniCAT00396 MiniCAT00194 ENT00080 MiniCAT00171 MiniCAT00244

Distribution pattern

Nationwide Distribution