Exact FDA event identifier

Event 66344

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

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Event summary

Timeline bucket: December 14, 2009
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Xoran Technologies, 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

Xoran MiniCAT CT Scanner ID ENT00001

Z-0041-2014

Recall number: Z-0041-2014
Initiated: December 14, 2009
Classification: Class II
Status: Terminated
Recalling firm: Xoran Technologies, Inc.
Quantity: 320

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate.

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

Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate.

Code information

minicat

Distribution pattern

Worldwide Distribution - US nationwide