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Canon Medical System, USA, INC.: Alphenix INFX-8000C/B5

Medical DevicesSource: FDA (device) · Date: 2026-10-14

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Canon Medical System, USA, INC.
Product
Alphenix INFX-8000C/B5
Reason / 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
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the state of ID.
Recall initiated
2026-08-26
Code info
Serial no. B5F2532011/UDI: 4987670100192
Product quantity
1 unit
Voluntary mandated
Voluntary: Firm initiated
City
Tustin
State
CA
Country
United States
Event id
99817
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