B-K Medical A/S: bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

Hazard

An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.

Details from the source

Reason for recall: An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error. Distribution: US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, ID, IL, KS, MA, MD, MI, MO, NC, NE, NJ, NY, OH, PA, RI, SC, TX, UT, VA, WA, WI, and WV. Quantity: N/A Lot/code info: All bkActive (2300-56 and 2300-66) Ultrasound systems, GTIN 05704916000264.

UPC codes

05704916000264

Source

Official record: FDA (Device enforcement) ↗

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