Class 2 Device Recall BK Medical ApS Ultrasound System Scanner

• Date Initiated by Firm: June 28, 2016
• Create Date: August 03, 2016
• Recall Status: Terminated on August 29, 2016
• Recall Number: Z-2325-2016
• Recall Event ID: 74691
• 510(K)Number: K140428 K143298 K151910 K152052
• 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
• FEI Number: 3003705156
• 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: 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; 510(K)s with Product Code = IYN