Device product
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
Z-0813-2024
Product summary
- Firm
- B-K Medical A/S
- Event
- Event 93598
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0813-2024
Official wording
Reason: An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
Code information: All bkActive (2300-56 and 2300-66) Ultrasound systems, GTIN 05704916000264.
Distribution pattern: 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.
Derived failure modes
-
Unknown
An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.