Recall Z-3014-2026— Canon Medical System, USA, INC.
Class II · Ongoing
Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2026-08-04. It names 3 FDA 510(k) clearances: K210900, K203551, K182415. Product: Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.. Reason: Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose..
- Recalling firm
- Canon Medical System, USA, INC.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-04
- Firm location
- Tustin, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K210900 — Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
- K203551 — Alphenix, INFX-8000V/B, /S, V9.1
- K182415 — Alphenix, INFX-8000F/B, V8.0
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 Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Reason for recall
Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
Data sourced from openFDA. This site is unofficial and independent of the FDA.