# FDA recall Z-1269-2021

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2020-12-08.

## Product

Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V     Catheterization Table CAT-880B  Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.

## Reason for recall

System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.

## Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, WA, WI and WV. The countries of  Canada, China, Japan, Korea, and Singapore.

## Key facts

- **Recall number:** Z-1269-2021
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-12-08
- **Report date:** 2021-03-24

- **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-1269-2021

## Citation

> AI Analytics. FDA recall Z-1269-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1269-2021. Source: US FDA. Licensed CC0.

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