Z-0813-2024Class II

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

Name: Z-0813-2024 bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66
Creator: B-K Medical A/S
Published: 2023-11-30
License: https://open.fda.gov/license/

BK Medical ApS / initiated 2023-11-30 / Open, Classified / root cause: manufacturing process

FDA source

B-K Medical A/S began a recall of bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66 on 2023-11-30. FDA classified it as Class II and gives the reason as "An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0813-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-30
Posted: 2024-01-25
Recalling firm: BK Medical ApS
Product: bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
Root cause tag: manufacturing process
FDA 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.
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 codes and lots: All bkActive (2300-56 and 2300-66) Ultrasound systems, GTIN 05704916000264.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0813-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0813-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-25

Product code IYN

K223830Class IIUltrasound System 2300Bk Medical Aps / cleared 2023-04-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)