Change Healthcare Enterprise Viewer — Class II medical device recall Z-1773-2021
Ongoing recall by CHANGE HEALTHCARE CANADA COMPANY, reported 2021-06-09, distributed nationwide. A software defect was identified where the Image Styles defined by presentation states from CHRS are not displ
| Recall number | Z-1773-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CHANGE HEALTHCARE CANADA COMPANY, Richmond, Canada |
| Recall initiated | 2021-04-19 |
| Classified | 2021-06-02 |
| Reported by FDA | 2021-06-09 |
| Distributed | Nationwide (US) |
| Quantity | 33 devices |
| Reason classes | software |
Product
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.
Reason for recall
A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
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-1773-2021. 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.