FDAFDA · Food and drugs·Recall number Z-0958-2025
Change Healthcare Cardiology Hemo software
Published January 22, 2025 · Recall initiated: December 2, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- A L I Technologies Ltd
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.