B-K Medical A/S Mileparken 34 Herlev Denmark bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
Brand
B-K Medical A/S Mileparken 34 Herlev Denmark
Lot Codes / Batch Numbers
All bkActive (2300-56 and 2300-66) Ultrasound systems, GTIN 05704916000264.
Products Sold
All bkActive (2300-56 and 2300-66) Ultrasound systems, GTIN 05704916000264.
B-K Medical A/S Mileparken 34 Herlev Denmark is recalling bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66. due to An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026