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

FDA device recall Z-0813-2024 · posted 2024-01-25 · Open, Classified

Recall details

Recalling firm

B-K Medical A/S

Reason for recall

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

Action taken

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.

Root cause

Process design

Status

Open, Classified

Product code

IYN

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.

Date initiated

2023-11-30

Date posted

2024-01-25

Location

Herlev, Denmark

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