# FDA recall Z-0492-2022

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2021-12-20.

## Product

Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.

## Reason for recall

Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable image may remove a catheter from the patient's blood vessel and damage the blood vessel.

## Distribution

US Nationwide distribution in the states of DE, FL, LA, MT, NJ, OH, and  WV.

## Key facts

- **Recall number:** Z-0492-2022
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-12-20
- **Report date:** 2022-01-19

- **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-0492-2022

## Citation

> AI Analytics. FDA recall Z-0492-2022. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0492-2022. Source: US FDA. Licensed CC0.

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