bk3000, model #2300-11 recallZ-0136-2025 · B-K Medical A/S · initiated Sep 4, 2024
Class II Open, Classified All recalls posted in October 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from B-K Medical A/S or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0136-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Sep 4, 2024
- Posted by the FDA
- Oct 18, 2024
- Recalling firm
- B-K Medical A/S
- Quantity
- 1648 devices
- Product code
- IYN
- FDA submissions
- K223830
- 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.
Product description
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 (models, lots, serial numbers)
All serial numbers, GTIN 05704916000264.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- bk3000, bk3500, bk5000, bkActiv 2300Bk Medical Aps · Transducer, Ultrasonic, Diagnostic6 recalls1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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