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 | Due to complaints, software update may cause software to unexpectedly shutdown. |
| Product | Change Healthcare Cardiology Hemo Software |
| Quantity | 29 systems |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, KY MO, MS, NE, NH, NJ, PA, TN, TX, WA and the countries of Australia, Canada, Germany, Great Britain, Ireland, Israel, New Zealand. |
| Initiated | 2025-05-22 |
| Classified | 2025-07-02 |
| Recall number | Z-2071-2025 |
| 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-2071-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97046/
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