Summary
The FDA issued a Class II for Alphenix INFX-8000C/B5 by Canon Medical System, USA, INC.. Reason: Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalig.
Details
Source
Device Recall
External ID
Z-0108-2027
Action Date
2026-10-14
Status
Ongoing
Category
device
Product Description
Alphenix INFX-8000C/B5
Lot/Code Info: Serial no. B5F2532011/UDI: 4987670100192
Quantity Affected: 1 unit
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
Distribution
US Nationwide distribution in the state of ID.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-26
Company
Tustin, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 220 device recalls issued in the same week, part of 502 device-related FDA actions this month.
Canon Medical System, USA, INC. has 23 FDA actions in our database, including 23 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Canon Medical System, USA, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Canon Medical System, USA, INC. have FDA actions?
Canon Medical System, USA, INC. has 23 FDA actions in our database, including 23 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0108-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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