Carestream Vue PACS — Class II medical device recall Z-0259-2014
Terminated recall by Carestream Health Inc., reported 2013-11-20, distributed in AR, AZ, CA, CO, CT, FL, IA, IL…. Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very spec
| Recall number | Z-0259-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health Inc., Rochester, NY, United States |
| Recall initiated | 2013-09-16 |
| Classified | 2013-11-13 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2015-12-21 |
| Distributed | AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA, WA, WI |
| Countries outside the US | CA, JP, KW |
| Reason classes | software |
| Model numbers | 8441602 |
Product
Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Reason for recall
Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
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-0259-2014. 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.