FDA Medical Device Recalls (openFDA)
B-K Medical A/S: bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
- Recall number
- Z-0813-2024
- Recalling firm
- B-K Medical A/S
- Product
- bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
- Status
- Open, Classified
- Initiated
- 2023-11-30
- Posted
- 2024-01-25
- Terminated
- not on file
- Reason
- An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
- Root 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.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- All bkActive (2300-56 and 2300-66) Ultrasound systems, GTIN 05704916000264.
- 510(k) numbers
- ["K223830"]
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 3003705156
- Firm city
- Herlev
- Firm state
- not on file
- Firm country
- Denmark
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28