bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound sy

FDA device recall Z-0136-2025 · posted 2024-10-18 · Open, Classified

Recall details

Recalling firm

B-K Medical A/S

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.

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.

Root cause

Process control

Status

Open, Classified

Product code

IYN

Quantity affected

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, Denm

Date initiated

2024-09-04

Date posted

2024-10-18

Location

Herlev, Denmark

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