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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65369

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

Open FDA event record

Event summary

Timeline bucket
June 03, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Carestream Health 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

Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

Z-1877-2013
Recall number
Z-1877-2013
Initiated
June 03, 2013
Classification
Class II
Status
Terminated
Recalling firm
Carestream Health Inc.
Quantity
US: 49 units; Foreign: 183 units (revised)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to potential for an x-ray exposure technique change.

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

Due to potential for an x-ray exposure technique change.

Code information

Carestream DRX Evolution Systems using V5.5.410.33 MR2 Software

Distribution pattern

Worldwide Distribution - USA (nationwide) including the countries of Austria, Australia, Belgium, Canada, China, Finland, France, Germany, Italy, Korea, Kuwait, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom.