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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66833

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

Open FDA event record

Event summary

Timeline bucket
November 07, 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

EOS System X- ray beam Digital radiography system used in general radiographic examinations.

Z-0529-2014
Recall number
Z-0529-2014
Initiated
November 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
EOS Imaging
Quantity
22 EOS systems are installed in US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition.

Code information

EOS System

Distribution pattern

Nationwide Distribution

Field note

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