Notice names this product. Canon Medical System’s Alphenix INFX-8000C/B5 is named in FDA Class II recall Z-0108-2027. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error Identifying details: Serial no. B5F2532011/UDI: 4987670100192. Units affected: 1 unit. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Alphenix INFX-8000C/B5
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motio…
Company / brand: Canon Medical System recalls
Affected product: Alphenix INFX-8000C/B5 recall status
Official ID Z-0108-2027 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 12:00 PM UTC.