← FDA ENFORCEMENT
Z-0108-2027Class II
Canon Medical System, USA, INC.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Canon Medical System, USA, INC.
Product type
Device
Status
Ongoing
Report date
2026-10-14
Distribution
US Nationwide distribution in the state of ID.
Firm state
CA
Product quantity
1 unit
Initiated by
Voluntary: Firm initiated
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
Product description
Alphenix INFX-8000C/B5
Code / lot info
Serial no. B5F2532011/UDI: 4987670100192
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →