Z-0813-2024 Class II Ongoing
FDA device recall Z-0813-2024 was initiated by B-K Medical A/S on November 30, 2023 and is designated Class II. Reason for recall: An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- January 31, 2024
- Initiation Date
- November 30, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
Reason for Recall
An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
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.
Code Information
All bkActive (2300-56 and 2300-66) Ultrasound systems, GTIN 05704916000264.