Exact FDA event identifier

Event 64734

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

Open FDA event record

Event summary

Timeline bucket: September 26, 2012
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: DeGotzen

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

DeGotzen XRay unit XGenus Dental X-ray unit.

Z-1020-2013

Recall number: Z-1020-2013
Initiated: September 26, 2012
Classification: Class II
Status: Terminated
Recalling firm: DeGotzen
Quantity: 159 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification

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

It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification

Code information

766471

Distribution pattern

US (nationwide)