# FDA recall Z-0360-2020

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2019-02-08.

## Product

Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.

## Reason for recall

Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, CT, FL, IL, OR, PA, and TX; and country of  Netherlands.

## Key facts

- **Recall number:** Z-0360-2020
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-08
- **Report date:** 2019-11-20
- **Termination date:** 2022-06-07

- **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-0360-2020

## Citation

> AI Analytics. FDA recall Z-0360-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0360-2020. Source: US FDA. Licensed CC0.

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