FDA Device recall Z-0959-2025
Change Healthcare Cardiology Hemodynamics software
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of Change Healthcare Cardiology Hemodynamics software by A L I Technologies, citing software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0959-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-02 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | A L I Technologies |
| Distribution | US |
Product
Change Healthcare Cardiology Hemodynamics software
Reason
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Identifiers
| code_info | Software version 15.01/UDI:(01)17540262100129 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0959-2025%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.