B-K Medical bkActiv Ultrasound System 2300: Measurement Error Risk

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Recalling firmB-K Medical A/SMileparken 34, N/A · Herlev, N/A N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

B-K Medical is recalling two models of their bkActiv Ultrasound System 2300 (2300-56 and 2300-66) because a software feature could cause measurement errors. This might lead to incorrect medical readings, which could affect patient care.

Why it’s dangerous

The Dual Live Compare feature in the system may produce inaccurate measurements. This could lead to incorrect medical assessments if the device is used for critical diagnostic purposes.

Who’s affected

Healthcare providers using the bkActiv Ultrasound System 2300 models 2300-56 and 2300-66 are most at risk, as measurement errors could impact medical decisions.

How to tell if you have this one

Check for model numbers 2300-56 or 2300-66 on the bkActiv Ultrasound System 2300. Affected units also have GTIN 05704916000264.

Brand
B-K Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Number
Look for model numbers 2300-56 or 2300-66 on the device.

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

The recall is for potential measurement errors, which could affect medical accuracy but do not pose a direct safety risk like injury or fire.

How can I tell if my device is affected?

Check for model numbers 2300-56 or 2300-66 on the bkActiv Ultrasound System 2300, or look for GTIN 05704916000264.

What should I do if I have this device?

The recall does not require immediate action; check the model number to see if it's affected.

Take action

Contact B-K Medical

We’ve drafted a message you can send B-K Medical to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0813-2024 — B-K Medical B-K Medical

Hello,

I own a B-K Medical that is covered by recall Z-0813-2024 from B-K Medical.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0813-2024 (November 30, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0813-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

B-K Medical A/S recalls bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

Lower-risk recall