GE HealthCare and B-K Medical A/S have issued a recall for the bkSpecto Ultrasound System 1300 (Model 1300-21 and 1300-S1) with battery units. The recall was initiated because the Instructions for Use in the user guide and service manual do not provide sufficient information regarding battery safety. Specifically, the manuals lack required battery replacement intervals, end-of-life handling procedures, and general safety precautions.
Inadequate instructions regarding battery maintenance and end-of-life handling can lead to battery failure or safety hazards during use. This may result in the ultrasound system failing during a critical medical procedure or posing general electrical safety risks to operators and patients.
Information Correction/Supplement
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.
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Sources: FDA iRES · Raw API Response
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