bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.

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.

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.