# Class II recall Z-0108-2027: Canon Medical System, USA, INC.

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0108-2027 |
| Recalling firm | Canon Medical System, USA, INC. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Alphenix INFX-8000C/B5 |
| Reason | 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 |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of ID. |
| Recall initiated | 2026-08-26 |
| Reported | 2026-10-14 |
| Firm location | Tustin, CA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 22 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0108-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.