FDA Enforcement
Class II
Ongoing
Change Healthcare Cardiology Hemodynamics Software
Recall: Z-2072-2025
·
Reported July 9, 2025
Enforcement
- Recall Number
- Z-2072-2025
- Event ID
- 97046
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- CHANGE HEALTHCARE CANADA COMPANY
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- July 9, 2025
- Initiation Date
- May 22, 2025
- Classification Date
- July 2, 2025
- Address
- 10711 Cambie Rd Suite 130, Richmond, N/A, Canada
Description
Change Healthcare Cardiology Hemodynamics Software
Reason
Due to complaints, software update may cause software to unexpectedly shutdown.
Code Info
Software version: 15.0.1/UDI: (01)17540262100129
Distribution
Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, KY MO, MS, NE, NH, NJ, PA, TN, TX, WA and the countries of Australia, Canada, Germany, Great Britain, Ireland, Israel, New Zealand.
Quantity
4 systems