Horizon Cardiology Hemo — Class II medical device recall Z-1489-2019
Terminated recall by Change Healthcare Israel Ltd., reported 2019-06-05, distributed nationwide. users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes
| Recall number | Z-1489-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Change Healthcare Israel Ltd., Holon, N/A, Israel |
| Recall initiated | 2019-03-25 |
| Classified | 2019-05-24 |
| Reported by FDA | 2019-06-05 |
| Terminated | 2025-03-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, GB, IE, IL |
| Quantity | 125 devices |
Product
Horizon Cardiology Hemo
Reason for recall
users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in Horizon/McKesson Cardiology Hemo" (Hemo). The discrepancy may also affect administered medication data in reports generated from Hemo or the Horizon/McKesson Cardiology Physician s Report as well as customers, who have implemented an outbound interface of procedure results.
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-1489-2019. 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.