Class 2 Device Recall 2300 (bk3000, bk3500, bk5000, bkActiv)

• Date Initiated by Firm: September 04, 2024
• Date Posted: October 18, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0136-2025
• Recall Event ID: 95431
• 510(K)Number: K223830
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
• Code Information: All serial numbers, GTIN 05704916000264.
• FEI Number: 3003705156
• Recalling Firm/ Manufacturer: B-K Medical A/S; Mileparken 34; Herlev Denmark
• For Additional Information Contact: BK Medical Service; 800-645-4442
• Manufacturer Reason for Recall: The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable.
• FDA Determined Cause: Process control
• Action: Notifications were issued on and dated 9/4/2024 informing the consignee of the safety issue and the actions to be taken, which included: Until GE HealthCare implements a permanent correction on the device for this issue, the consignee is to inspect the power cord connection at the power inlet to the ultrasound device. A photograph of the area to be inspected was embedded in the letter. If a cord retaining bracket is not present, the consignee is to ensure the power cord is fully pushed into the power inlet before each use and while the ultrasound device is charging. If a cord retaining bracket is present, no further action is required. The consignee is to ensure all potential staff in the facility are made aware of the safety notification and the recommended actions. An acknowledgment form was enclosed for completion and return.
• Quantity in Commerce: 1648 devices
• Distribution: Worldwide - US Nationwide - There was also government/military distribution and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, and United Kingdom.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IYN