FDA Device recall Z-1489-2019
Horizon Cardiology Hemo
- FDA Device
- Class II
- terminated
- Published 2019-06-05
On 2019-06-05 the FDA classified a Class II recall of Horizon Cardiology Hemo by Change Healthcare Israel, citing 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"….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1489-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-25 |
| Published | 2019-06-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Change Healthcare Israel |
| Distribution | US |
Product
Horizon Cardiology Hemo
Reason
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.
Identifiers
| code_info | Software version 11.x and 12.x |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1489-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.