Recall Z-0813-2024 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
B-K Medical A/S
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
| Date | Jan 25, 2024 (initiated Nov 30, 2023) |
| Status | Open, Classified |
| Reason | An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error. |
| 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 vi |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223830 | Ultrasound System 2300 Bk Medical Aps, Apr 11, 2023 |