FDAClass IIJanuary 31, 2024

bkActiv Ultrasound System 2300 recall

bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

Why was bkActiv Ultrasound System 2300 recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All bkActive (2300-56 and 2300-66) Ultrasound systems, GTIN 05704916000264.

Product
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
Recalling firm
B-K Medical A/S
Quantity
N/A
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.
Recall date
January 31, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls