bkActiv Ultrasound System 2300, Model numbers 2300-56 and… recallZ-0813-2024 · B-K Medical A/S · initiated Nov 30, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from B-K Medical A/S or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-0813-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 30, 2023
- Posted by the FDA
- Jan 25, 2024
- Recalling firm
- B-K Medical A/S
- Product code
- IYN
- FDA submissions
- K223830
- 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.
Product description
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
Code information (models, lots, serial numbers)
All bkActive (2300-56 and 2300-66) Ultrasound systems, GTIN 05704916000264.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- bk3000, bk3500, bk5000, bkActiv 2300Bk Medical Aps · Transducer, Ultrasonic, Diagnostic6 recalls1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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