B-K Medical A/S is recalling 1,648 units of various ultrasound systems including the bk3000, bk3500, bk5000, and bkActive 2300 models with a battery option. The internal power connections on these devices can loosen over time, leading to excessive heat buildup or making the device stop working during use. This defect creates a risk of "thermal events," such as smoke or fire, which could cause injury or delay critical medical procedures. Consumers should contact the manufacturer or their healthcare facility's equipment manager to confirm if their specific device is affected and to arrange for a repair.
Loose power connections at the device's inlet can generate extreme heat, potentially leading to smoke, fire, or the system becoming inoperable during clinical use. This poses a fire risk to users and patients, and could result in clinical delays if the device fails while being used for a procedure.
Manufacturer initiated contact via letter
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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