Recall Z-0108-2027— Canon Medical System, USA, INC.

Name: FDA recall Z-0108-2027
Creator: U.S. Food and Drug Administration
Published: 2026-08-26

Class II · Ongoing

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2026-08-26. It names one FDA 510(k) clearance: K210900. 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.

Recalling firm: Canon Medical System, USA, INC.
Classification: Class II
Status: Ongoing
Initiated: 2026-08-26
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K210900 — Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation·cleared 2021-04-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Alphenix INFX-8000C/B5

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.