FDA Device recall Z-1508-2021
Change Healthcare Enterprise Viewer
- FDA Device
- Class II
- ongoing
- Published 2021-05-05
On 2021-05-05 the FDA classified a Class II recall of Change Healthcare Enterprise Viewer by Change Healthcare Canada, citing change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1508-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-03-17 |
| Published | 2021-05-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Change Healthcare Canada |
| Distribution | AK, AZ, CA, FL, HI, IA, IL, IN, KY, MI, NE, NY, OH, PA, TX, WA, WI, WY |
Product
Change Healthcare Enterprise Viewer
Reason
Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.
Identifiers
| code_info | Change Healthcare Enterprise Viewer 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-1508-2021%22
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