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Alphenix INFX-8000C/B5

Class II
Recalling firm
Canon Medical System, USA, INC.
Reason for recall
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 (lot / model / serial)
Serial no. B5F2532011/UDI: 4987670100192
Units affected
1 unit
Distribution pattern
US Nationwide distribution in the state of ID.
Firm location
Tustin, CA, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
E-Mail
Product type
Devices
Status
Ongoing
Recall number
Z-0108-2027
Recall initiated
August 26, 2026
FDA classification date
October 7, 2026
FDA report date
October 14, 2026
FDA event ID
99817
Last updated on HTM Vibe
October 21, 2026
View on openFDA