FDA recall Z-0959-2025

A L I Technologies Ltd · Class II · device

Product

Change Healthcare Cardiology Hemodynamics software

Reason for recall

Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2024-12-02
Report date
2025-01-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Burnaby, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0959-2025