Device product
Change Healthcare Cardiology Hemo software
Z-0958-2025
Product summary
- Event
- Event 96025
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 204 units
- Official record key
device-enforcement:Z-0958-2025
Official wording
Reason: Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Code information: Software version/UDI: 14.1.1/(01)17540262100020, 14.2/(01)17540262100037, 14.3/(01)17540262100044, 14.3.2/(01)17540262100051, 15.01/(01)17540262100105, 15.1/(01)17540262100129
Distribution pattern: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PA, SC, SD, TN, TX, WA, WI and the countries of Australia, Israel, Canada, Germany, Ireland, United Kingdom.
Derived failure modes
-
Device software or design
Software defect