B-K Medical A/S: Medical Device Recall in 2016 - (Recall #: Z-2325-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN

Product Classification:

Class II

Date Initiated: June 28, 2016

Date Posted: August 10, 2016

Recall Number: Z-2325-2016

Event ID: 74691

Reason for Recall:

In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be unaware of the calculation factor (1) and assume the generic volume calculation factor is similar to that of the other (prostate, adenoma, testis, kidney, and bladder) volume calculation factors provided in the software.

Status: Terminated

Product Quantity: 6

Code Information:

Serial Numbers: 5007750, 5008004, 5007734,5007742, 5007596, and50074277

Distribution Pattern:

Worldwide Distribution - US to TX, FL, and MA. Internationally to Australia

Voluntary or Mandated:

Voluntary: Firm initiated