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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67188

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

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Event summary

Timeline bucket
December 26, 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

KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.

Z-0844-2014
Recall number
Z-0844-2014
Initiated
December 26, 2013
Classification
Class II
Status
Terminated
Recalling firm
Carestream Health, Inc.
Quantity
164 units Total (42 domestically & 122 internationally)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software due to a possible patient image display error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error.

Code information

Service Code: 8087; Catalog numbers: 8791345, 1155118, 1295088, 8551046, 8791345, 1666700, 8531675

Distribution pattern

worldwide Distribution - US (Nationwide) including states of: IN, PA, MD, MI, NY, GA, MN, OK, VA, TX, WI, CA, IL, TN, WA, NC, SC, MA, NJ, and KY; and Internationally to: Canada, New Zealand, South Korea, Australia, Hong Kong, Saudia Arabia, Guinea, Kuwait, Israel, Oman, South Africa, China, UK, Sweden, Poland, Denmark, Germany, Finland, Czech Republic, Italy, France, Portugal and Spain.