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Recall Observatory FDA recall evidence

Device product

Change Healthcare Cardiology Hemo software

Z-0958-2025

December 02, 2024

Class II

Product summary

Firm
A L I Technologies Ltd
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

    reason.device_software_design · v1.0.0

    Software defect