FDA Device recall Z-1773-2021
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and…
- FDA Device
- Class II
- ongoing
- Published 2021-06-09
On 2021-06-09 the FDA classified a Class II recall of Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and… by Change Healthcare Canada, citing A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1773-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-04-19 |
| Published | 2021-06-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Change Healthcare Canada |
| Distribution | US |
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
A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
Identifiers
| code_info | Software version 2.0 and 2.1. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1773-2021%22
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