Alphenix INFX-8000C/B5
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
| Recalling firm | 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] misalignment and a longitudinal motion error |
| Risk class | Class II (Class II · moderate) |
| Status | Ongoing |
| Report date | Oct 14, 2026 |
| Initiated | Aug 26, 2026 |
| Region | CA, United States |
| Distribution | US Nationwide distribution in the state of ID. |
| Quantity | 1 unit |
| Code/Lot | Serial no. B5F2532011/UDI: 4987670100192 |
| Type | Voluntary: Firm initiated |
| Recall number | Z-0108-2027 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: Z-0108-2027)
openFDA (U.S. Food & Drug Administration) — food/drug/device enforcement · CC0 1.0 (public domain)
Find out more
- Search this recall on FDA fda.gov ↗
- Search related news (Google News) news.google.com ↗
- Search this product (Google) google.com ↗
The links above open external searches by recall number / product name; the results are the responsibility of each site.
This page summarizes U.S. FDA data for general information and is not medical advice. Confirm details via official FDA announcements and the manufacturer.