Reported Aug 10, 2016 · Terminated
BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The…
B-K Medical A/S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: B-K Medical A/S · Mileparken 34 · Herlev · N/A
Is this the product you have?
- 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 areasEmergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN
- Lot codes and dates
- Serial Numbers
50077505008004500773450077425007596and50074277
- Serial Numbers
- Amount recalled
- 6
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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