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  "name": "Brand Name: HiResolution\" Bionic Ear System  Product Name: M Zn-Air Battery Pak  Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280  Software Version: Not Applicable  Product Description: The M Zn-Air Battery Pak is a disposable power source for the Naida\" CI M and Sky CI\" M Sound Processors. The type of disposable battery to be used with the M Zn-Air Battery Pak is a 675 power implant battery (P675). Regular 675 hearing instrument batteries will not be powerful enough for a cochlear implant. The suggested manufacturer and battery is PowerOne P675 Implant Plus battery.    The M Zn-Air Battery Pak is available with non-tamperproof and tamperproof cartridges.  Component: Not Applicable",
  "description": "FDA recall Z-1950-2026 — Advanced Bionics, LLC is recalling Brand Name: HiResolution\" Bionic Ear System  Product Name: M Zn-Air Battery Pak  Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280  Software Version: Not Applicable  Product Description: The M Zn-Air Battery Pak is a disposable power source for the Naida\" CI M and Sky CI\" M Sound Processors. The type of disposable battery to be used with the M Zn-Air Battery Pak is a 675 power implant battery (P675). Regular 675 hearing instrument batteries will not be powerful enough for a cochlear implant. The suggested manufacturer and battery is PowerOne P675 Implant Plus battery.    The M Zn-Air Battery Pak is available with non-tamperproof and tamperproof cartridges.  Component: Not Applicable (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Brand Name: HiResolution\" Bionic Ear System  Product Name: M Zn-Air Battery Pak  Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280  Software Version: Not Applicable  Product Description: The M Zn-Air Battery Pak is a disposable power source for the Naida\" CI M and Sky CI\" M Sound Processors. The type of disposable battery to be used with the M Zn-Air Battery Pak is a 675 power implant battery (P675). Regular 675 hearing instrument batteries will not be powerful enough for a cochlear implant. The suggested manufacturer and battery is PowerOne P675 Implant Plus battery.    The M Zn-Air Battery Pak is available with non-tamperproof and tamperproof cartridges.  Component: Not Applicable",
    "manufacturer": {
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      "name": "Advanced Bionics, LLC"
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      "name": "FDA recall Z-1950-2026: Advanced Bionics, LLC is recalling Brand Name: HiResolution\" Bionic Ear System  Product Name: M Zn-Air Battery Pak  Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280  Software Version: Not Applicable  Product Description: The M Zn-Air Battery Pak is a disposable power source for the Naida\" CI M and Sky CI\" M Sound Processors. The type of disposable battery to be used with the M Zn-Air Battery Pak is a 675 power implant battery (P675). Regular 675 hearing instrument batteries will not be powerful enough for a cochlear implant. The suggested manufacturer and battery is PowerOne P675 Implant Plus battery.    The M Zn-Air Battery Pak is available with non-tamperproof and tamperproof cartridges.  Component: Not Applicable",
      "text": "The FDA logged enforcement record Z-1950-2026: Advanced Bionics, LLC is voluntarily recalling Brand Name: HiResolution\" Bionic Ear System  Product Name: M Zn-Air Battery Pak  Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280  Software Version: Not Applicable  Product Description: The M Zn-Air Battery Pak is a disposable power source for the Naida\" CI M and Sky CI\" M Sound Processors. The type of disposable battery to be used with the M Zn-Air Battery Pak is a 675 power implant battery (P675). Regular 675 hearing instrument batteries will not be powerful enough for a cochlear implant. The suggested manufacturer and battery is PowerOne P675 Implant Plus battery.    The M Zn-Air Battery Pak is available with non-tamperproof and tamperproof cartridges.  Component: Not Applicable — reason: The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-03-23. Affected lots/codes: Lot Code: All lots manufactured up to February 3, 2026.  Refer to Exhibit_0006. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1950-2026 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
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      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
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      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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            "Value": "The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.",
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            "Value": "Lot Code: All lots manufactured up to February 3, 2026.  Refer to Exhibit_0006",
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            "Field": "Distribution pattern",
            "Value": "Worldwide - U.S Nationwide distribution including in the state of AK, AL, AR, AZ, CA, CO, CT, CD, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Canada, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, China, Chile, Croatia, Cuba, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kazakhstan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, United Arab Emirates, and United Kingdom.",
            "Status": "recorded"
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