Change Healthcare Cardiology Hemo Software — Class II medical device recall Z-2071-2025
Ongoing recall by CHANGE HEALTHCARE CANADA COMPANY, reported 2025-07-09, distributed nationwide. Due to complaints, software update may cause software to unexpectedly shutdown.
| Recall number | Z-2071-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CHANGE HEALTHCARE CANADA COMPANY, Richmond, Canada |
| Recall initiated | 2025-05-22 |
| Classified | 2025-07-02 |
| Reported by FDA | 2025-07-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, GB, IE, IL, NZ |
| Quantity | 29 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 17540262100051, 17540262100105 |
Product
Change Healthcare Cardiology Hemo Software
Reason for recall
Due to complaints, software update may cause software to unexpectedly shutdown.
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-2071-2025. 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.