bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
This recall is currently active, issued October 18, 2024. It was issued by B-K Medical A/S Mileparken 34 Herlev Denmark.
- Recall Initiated
- September 4, 2024
- Posted
- October 18, 2024
- Recall Number
- Z-0136-2025
- Quantity
- 1648 devices
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
All serial numbers, GTIN 05704916000264.
Root Cause
Process control
Action Taken
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.