Class 2 Device Recall bkActiv Ultrasound System 2300

• Date Initiated by Firm: November 30, 2023
• Date Posted: January 25, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0813-2024
• Recall Event ID: 93598
• 510(K)Number: K223830
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
• Code Information: All bkActive (2300-56 and 2300-66) Ultrasound systems, GTIN 05704916000264.
• FEI Number: 3003705156
• Recalling Firm/ Manufacturer: B-K Medical A/S; Mileparken 34; Herlev Denmark
• For Additional Information Contact: 800-6454442
• Manufacturer Reason for Recall: An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
• FDA Determined Cause: Process design
• Action: The firm issued letters dated 11/30/2023 via FedEx to the following titles at the consignee locations: Head of Surgical Operations, Head of Ultrasound Department, Hospital Administrator / Risk Managers, and Head of Clinical Engineering. The letter explained the issue and informed the consignee they can continue to use the ultrasound system. Before using the Dual Live Compare, they are to consult the user manual (specific site provided) to ensure that the scanning depth in the Live image is the same as the Stored image. Photographs of the bkActiv screen were provided for the consignee to view. The consignee is to ensure all potential users in the facility are made are of the correction notification and the recommended actions. A link was provided for the acknowledgment form for the consignee to complete and return. All bkActive (2300-56 and 2300-66) Ultrasound Systems are affected but an appendix was provided containing a list of all affected serial numbers. The consignee was informed BK Medical will correct all affected products and a representative will contact the consignee to schedule a service visit to correct the issue.
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IYN