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.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
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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