FDA Device recall Z-0820-2015
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer by Carestream Health, citing reduced mammographic image quality when attempting to print true size multi-format images.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0820-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-30 |
| Published | 2014-12-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carestream Health |
| Distribution | NC, NY, OH |
Product
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Reason
Reduced mammographic image quality when attempting to print true size multi-format images
Identifiers
| code_info | Software Verions: 1) 5.7.312.27 , 2) 5.7.312.27, 3) 5.7.312.2031 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0820-2015%22
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