Official recall notice

FDA DeviceClass IINotable

Alphenix INFX-8000C/B5 Recall (Oct 2026) – Canon Medical System

Product: Alphenix INFX-8000C/B5

Recall date
2026-10-14
FDA class
Class II

Why it was recalled

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

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Product description

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

Affected products

Serial no. B5F2532011/UDI: 4987670100192

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