Class II — CHANGE HEALTHCARE CANADA COMPANY
| Recalling firm | Change Healthcare Canada Company |
|---|---|
| Registered facility | CHANGE HEALTHCARE CANADA COMPANY (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV. |
| 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. |
| Quantity | 33 devices |
| Distribution | US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IA, IN, IL, KY, NE, NY, MA, MI, MS, OH, PA, TX,TN, WA, WI, WY. |
| Initiated | 2021-04-19 |
| Classified | 2021-06-02 |
| Recall number | Z-1773-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CHANGE HEALTHCARE CANADA COMPANY (Z-1773-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87891/
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