[pending] Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Mode
Pending LLM rewrite. Source: FDA_DEVICE Z-2283-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Due to incorrect shelf-life expiration date.
The recalled product
- Product
- Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals
- Manufacturer
- Advanced Bionics, LLC
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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