Carestream DRX Evolution System — Class II medical device recall Z-1877-2013
Terminated recall by Carestream Health Inc., reported 2013-08-21, distributed nationwide. Due to potential for an x-ray exposure technique change.
| Recall number | Z-1877-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health Inc., Rochester, NY, United States |
| Recall initiated | 2013-06-03 |
| Classified | 2013-08-12 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2014-01-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CN, DE, ES, FI, FR, GB, IT, KR, KW, SA, SE, TW |
Product
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.
Reason for recall
Due to potential for an x-ray exposure technique change.
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-1877-2013. 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.