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 with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes" Ultra 3D receiver and either the HiFocus" SlimJ electrode or the HiFocus" Mid-Scala (MS) electrode array that are implanted surgically under the skin behind the ear. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. Component: N/A
USBrand 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 with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes" Ultra 3D receiver and either the HiFocus" SlimJ electrode or the HiFocus" Mid-Scala (MS) electrode array that are implanted surgically under the skin behind the ear. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. Component: N/A
Recalling Firm: Advanced Bionics, LLC
Grund für den Rückruf / Gefahr
TranslatedDue to incorrect shelf-life expiration date.
Produktbeschreibung & Identifikation
TranslatedBrand 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 with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes" Ultra 3D receiver and either the HiFocus" SlimJ electrode or the HiFocus" Mid-Scala (MS) electrode array that are implanted surgically under the skin behind the ear. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. Component: N/A
Betroffene Produkte
TranslatedBrand 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 with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes" Ultra 3D receiver and either the HiFocus" SlimJ electrode or the HiFocus" Mid-Scala (MS) electrode array that are implanted surgically under the skin behind the ear. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. Component: N/A
Additional Source Details
| Field | Value |
|---|---|
| City | Valencia |
| State | CA |
| Event id | 98916 |
| Address 1 | 28515 Westinghouse Pl |
| Code info | Model Number: CI-1601-04 UDI codes: (01)00840094455993(11)260220(17)290228(21)2225141 (01)00840094455993(11)260220(17)290228(21)2225150 (01)00840094455993(11)260220(17)290228(21)2225152 (01)00840094455993(11)260220(17)290228(21)2225155 (01)00840094455993(11)260220(17)290228(21)2225160 (01)00840094455993(11)260220(17)290228(21)2225188 (01)00840094455993(11)250929(17)280930(21)2227161 (01)00840094455993(11)260309(17)290331(21)2229827 (01)00840094455993(11)260309(17)290331(21)2229839 (01)00840094455993(11)260309(17)290331(21)2229849 (01)00840094455993(11)250918(17)280930(21)2214172 (01)00840094455993(11)260220(17)290228(21)2225146 (01)00840094455993(11)260220(17)290228(21)2225154 (01)00840094455993(11)260220(17)290228(21)2225168 (01)00840094455993(11)260220(17)290228(21)2225189 (01)00840094455993(11)250929(17)280930(21)2226476 (01)00840094455993(11)250929(17)280930(21)2227006 (01)00840094455993(11)250929(17)280930(21)2227007 (01)00840094455993(11)250929(17)280930(21)2227012 (01)0084009445... [TRUNCATED] |
| Postal code | 91355-1398 |
| Report date | 20260610 |
| Product type | Devices |
| Product quantity | 36 |
| Reason for recall | Due to incorrect shelf-life expiration date. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260430 |
| Initial firm notification | Letter |
| Center classification date | 20260601 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: C...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Übersicht
- Rückrufendes UnternehmenAdvanced Bionics, LLC
- StatusOngoing
- RisikostufeClass II
- DistributionU.S. Nationwide distribution in the states of CA, CO, GA, IL, IN, KS, MA, MD, MI, MO, MT, NC, TN, WA and WI.
📢 Warnung teilen
Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Advanced Bionics, LLC - 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 with severe-to-profound hearing loss. It consists of internal and external components. The internal components include the HiRes" Ultra 3D receiver and either the HiFocus" SlimJ electrode or the HiFocus" Mid-Scala (MS) electrode array that are implanted surgically under the skin behind the ear. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. Component: N/A Check if your household is affected: https://therecallfile.com/de/recalls/brand-name-hiresolution-bionic-ear-system-product-name-hires-ultra-3d/FDA-Z-2283-2026
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