KODAK DirectView DR 7500 Dual Detector System — Class II medical device recall Z-0844-2014
Terminated recall by Carestream Health, Inc., reported 2014-02-05, distributed nationwide. Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a poss
| Recall number | Z-0844-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health, Inc., Rochester, NY, United States |
| Recall initiated | 2013-12-26 |
| Classified | 2014-01-27 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2017-03-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, CZ, DE, DK, ES, FI, FR, GB, HK, IL, IT, KR, KW, NZ, OM, PL, PT, SE, ZA |
| Reason classes | software |
| Model numbers | 1155118, 1295088, 1666700, 7500, 8531675, 8551046, 8791345 |
Product
KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.