# FDA recall Z-2326-2020

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2020-03-03.

## Product

Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: 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

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

## Distribution

US Nationwide distribution including in the states of PA, AR, OH, NC, CA, IA, GA, IL, AL, WV, LA, MO, FL, MS, TX, AZ, MA, NJ, MD, NY, NV, OK, WI, PR.

## Key facts

- **Recall number:** Z-2326-2020
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-03-03
- **Report date:** 2020-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tustin, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2326-2020

## Citation

> AI Analytics. FDA recall Z-2326-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2326-2020. Source: US FDA. Licensed CC0.

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