FDA Device recall Z-2071-2025
Change Healthcare Cardiology Hemo Software
- FDA Device
- Class II
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class II recall of Change Healthcare Cardiology Hemo Software by Change Healthcare Canada, citing due to complaints, software update may cause software to unexpectedly shutdown.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2071-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-22 |
| Published | 2025-07-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Change Healthcare Canada |
| Distribution | US |
Product
Change Healthcare Cardiology Hemo Software
Reason
Due to complaints, software update may cause software to unexpectedly shutdown.
Identifiers
| code_info | Software version 14.3.2/UDI: (01)17540262100051/ 15.0.1/UDI: (01)17540262100105 |
|---|
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-2071-2025%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.