CLASS II ONGOING Device recall · Reported 31 Jan 2024 · FDA Enforcement Report
bkActiv Ultrasound System recalled by B-K Medical A/S
B-K Medical is recalling bkActiv Ultrasound System 2300, distributed nationwide in the US. The recall was initiated on 30 Nov 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0813-2024
- FDA event ID
- 93598
- Recalling firm
- B-K Medical, Herlev, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Nov 2023
- FDA classified
- 25 Jan 2024
- Reported
- 31 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 30 Nov 2023 | Recall initiated by company | |
| 25 Jan 2024 | Classified by FDA | +56 days |
| 31 Jan 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
Product as listed by the FDA
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaFloridaGeorgiaIdahoIllinoisKansasMassachusettsMarylandMichiganMissouriNorth CarolinaNebraskaNew JerseyNew YorkOhioPennsylvaniaRhode IslandSouth Carolina
Questions about this recall
Why was it recalled?
An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
Which lots are affected?
All bkActive (2300-56 and 2300-66) Ultrasound systems, GTIN 05704916000264.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from B-K Medical
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | bk3500 Ultrasound System w/battery recalled by B-K Medical A/S | B-K Medical | Device Malfunction | Nationwide |
| Device | CLASS II | bk3000 Ultrasound System w/battery recalled by B-K Medical A/S | B-K Medical | Device Malfunction | Nationwide |
| Device | CLASS II | 1202 Flex Focus Ultrasound System, cart recalled by B-K Medical A/S | B-K Medical | Device Malfunction | Nationwide |
| Device | CLASS II | UUltrasound System 2300, bkActiv w/battery recalled by B-K Medical A/S | B-K Medical | Device Malfunction | Nationwide |
| Device | CLASS II | bk5000 Ultrasound System w/battery recalled by B-K Medical A/S | B-K Medical | Device Malfunction | Nationwide |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |