Advanced Bionics, LLC is recalling 2 units of its Sky CI M90 Sound Processors, part of the HiResolution Bionic Ear System. The recall was initiated because the label on the outer packaging does not match the actual device inside. This labeling discrepancy could lead to a user or healthcare provider being misinformed about the specific device model or settings contained within the box.
If the packaging label does not match the included sound processor, there is a risk of confusion regarding the device's identity or specifications. This could potentially lead to errors in device management or programming for the cochlear implant user.
Quantity affected: 2 units. Packaging label does not match product.
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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