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U.S. Department of Health and Human Services

Class 2 Device Recall BK Medical ApS Ultrasound System Scanner

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  Class 2 Device Recall BK Medical ApS Ultrasound System Scanner see related information
Date Initiated by Firm June 28, 2016
Create Date August 03, 2016
Recall Status1 Terminated 3 on August 29, 2016
Recall Number Z-2325-2016
Recall Event ID 74691
510(K)Number K151910  K152052  K143298  K140428  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
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 performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN
Code Information Serial Numbers: 5007750, 5008004, 5007734,5007742, 5007596, and50074277
Recalling Firm/
Manufacturer		 B-K Medical A/S
Mileparken 34
Herlev Denmark
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action BK Medical sent an Important Corrective Action Notification letter dated June 27, 2016, to all affected customers. The letter explains the issue and asks customers to discontinue the use of the generic volume measurement and contact BK medical ApS Service for assistance. Customers with questions were instructed to call 800-645-4442.
Quantity in Commerce 6
Distribution Worldwide Distribution - US to TX, FL, and MA. Internationally to Australia
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = B-K MEDICAL APS
510(K)s with Product Code = IYN and Original Applicant = BK MEDICAL APS
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