Device product
Change Healthcare Cardiology Hemodynamics Software
Z-2072-2025
Product summary
- Event
- Event 97046
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 systems
- Official record key
device-enforcement:Z-2072-2025
Official wording
Reason: Due to complaints, software update may cause software to unexpectedly shutdown.
Code information: Software version: 15.0.1/UDI: (01)17540262100129
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.
Derived failure modes
-
Device software or design
software update may cause