BK Medical bk3500 Ultrasound Scanner Recalled for Volume Calculation Error
B-K Medical A/S is recalling six bk3500 ultrasound systems because the generic volume measurement function may display incorrect calculations, potentially affecting diagnostic accuracy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software calculation error that could lead to inaccurate diagnostic data, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving potential harm without reported adverse events.
Plain-English summary
B-K Medical A/S is recalling six units of the bk3500 Ultrasound System Scanner equipped with software releases 1.2.0, 1.2.1, and 1.2.2. The recall involves specific serial numbers: 5007750, 5008004, 5007734, 5007742, 5007596, and 50074277. These systems were distributed in the United States to Texas, Florida, and Massachusetts, as well as internationally to Australia.
The recall is due to a software defect in the generic volume measurement function (HxWxLxl). Users may be unaware of a specific calculation factor and might incorrectly assume it is similar to the factors used for other organ-specific volume calculations, such as those for the prostate, adenoma, testis, kidney, and bladder. This discrepancy could lead to inaccurate volume measurements during diagnostic imaging or fluid flow analysis.
The affected systems are intended for diagnostic ultrasound imaging, data processing, and guidance of puncture and biopsy in areas including Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, and OB/GYN. Healthcare facilities and users should contact B-K Medical A/S for instructions on how to address the software issue.
The recalled product
- Product
- 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…
- Manufacturer
- B-K Medical A/S
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Serial Numbers: 5007750
- 5008004
- 5007734
- 5007742
- 5007596
- and50074277
Distribution
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