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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

B-K Medical A/S: bkActiv Ultrasound Systems Recalled for Potential Measurement Errors

Agency Publication Date: January 25, 2024
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Summary

B-K Medical A/S has recalled the bkActiv Ultrasound System 2300, specifically model numbers 2300-56 and 2300-66. The recall was initiated because of a software issue in the Dual Live Compare feature that can cause the system to display incorrect measurements. These ultrasound systems were distributed to medical facilities across 26 states including California, Texas, and New York. Clinicians and healthcare providers should contact the manufacturer or their healthcare provider for further instructions regarding the necessary corrections for this device.

Risk

The software defect can result in inaccurate measurement data during medical imaging. This poses a risk that healthcare providers might rely on incorrect information when making diagnostic or treatment decisions for patients.

What You Should Do

  1. Identify if your facility uses the bkActiv Ultrasound System 2300 by checking for model numbers 2300-56 or 2300-66 and GTIN 05704916000264.
  2. Exercise caution when using the 'Dual Live Compare' feature on these systems, as measurements taken in this mode may be inaccurate.
  3. Refer to the notification letter sent by B-K Medical A/S on November 30, 2023, which contains specific instructions for affected users.
  4. Contact B-K Medical A/S or your healthcare provider for further instructions regarding software updates or potential corrections to the device.
  5. For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated correction via letter

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: bkActiv Ultrasound System 2300 (Model 2300-56)
Model / REF:
2300-56
05704916000264 (GTIN)
Product: bkActiv Ultrasound System 2300 (Model 2300-66)
Model / REF:
2300-66
05704916000264 (GTIN)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93598
Status: Active
Manufacturer: B-K Medical A/S
Sold By: Direct medical sales; Authorized distributors
Manufactured In: Denmark
Distributed To: Alabama, Arizona, California, Florida, Georgia, Idaho, Illinois, Kansas, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.