Exact FDA event identifier

Event 66980

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

Open FDA event record

Event summary

Timeline bucket: November 29, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: EOS Imaging

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

steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.

Z-0580-2014

Recall number: Z-0580-2014
Initiated: November 29, 2013
Classification: Class II
Status: Terminated
Recalling firm: EOS Imaging
Quantity: 36 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation

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

Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation

Code information

Software versions: 1.3, 1.4 and 1.5

Distribution pattern

USA Nationwide Distribution