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FDA (Device enforcement)Recalled 2024-12-02class ii

A L I Technologies Ltd: Change Healthcare Cardiology Hemo software

Hazard

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

Details from the source

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. Quantity: 204 units Lot/code info: 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

UPC codes

17540262100020, 17540262100037, 17540262100044, 17540262100051, 17540262100105, 17540262100129

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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