International Medical Devices Database

Manufacturer Address
B-K Medical A/S, Mileparken 34, Herlev Denmark
Manufacturer Parent Company (2017)
Bk Medical Holding Aps
Source
USFDA
1 Event
- Recall of Device Recall BK Medical ApS Ultrasound System Scanner

One device in the database

Device Recall BK Medical ApS Ultrasound System Scanner

Model / Serial
Serial Numbers: 5007750, 5008004, 5007734,5007742, 5007596, and50074277
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US to TX, FL, and MA. Internationally to Australia
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

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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B-K Medical A/S

One device in the database

Device Recall BK Medical ApS Ultrasound System Scanner