FDAFDA · Food and drugs·Recall number Z-0813-2024
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
Published January 31, 2024 · Recall initiated: November 30, 2023
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
An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- B-K Medical A/S
- Distributor
- 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.
- Lot
- All bkActive (2300-56 and 2300-66) Ultrasound systems, GTIN 05704916000264.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Denmark
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