CARESTREAM DIRECTVIEW CR Software Generates digital mammographic… — Class II medical device recall Z-0820-2015
Terminated recall by Carestream Health, Inc., reported 2014-12-24, distributed in NC, NY, OH. Reduced mammographic image quality when attempting to print true size multi-format images
| Recall number | Z-0820-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health, Inc., Rochester, NY, United States |
| Recall initiated | 2014-10-30 |
| Classified | 2014-12-16 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2017-03-10 |
| Distributed | NC, NY, OH |
| Countries outside the US | AR, BR, CL, CN, CO, ES, FR, GR, HK, IN, JP, KR, MX, PE, TH, TW |
| Quantity | 59 units |
Product
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Reason for recall
Reduced mammographic image quality when attempting to print true size multi-format images
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-0820-2015. 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.