DR 7500 with FF WS These products are permanently installed… — Class II medical device recall Z-0798-2014
Terminated recall by Carestream Health, Inc., reported 2014-01-29, distributed nationwide. Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak D
| Recall number | Z-0798-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health, Inc., Rochester, NY, United States |
| Recall initiated | 2013-11-25 |
| Classified | 2014-01-21 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2016-06-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CH, CN, DE, ES, FI, FR, GB, HK, IT, NL, NZ, PL, PT, SE, TR, TW |
| Model numbers | 1155118, 1295088, 1333483, 1666700, 1671841, 1845122, 8245607, 8531675, 8551046, 8649253, 8791345, 8864605, 8966780 |
Product
DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Reason for recall
Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0798-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.