Z-2071-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 9, 2025
- Initiation Date
- May 22, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 systems
Product Description
Change Healthcare Cardiology Hemo Software
Reason for Recall
Due to complaints, software update may cause software to unexpectedly shutdown.
Distribution Pattern
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.
Code Information
Software version 14.3.2/UDI: (01)17540262100051/ 15.0.1/UDI: (01)17540262100105