# FDA recall Z-0532-2021

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2020-10-08.

## Product

CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H - 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

There is a potential that the cable of the Flat panel detector may break during a procedure which may cause the x-ray device to stop before the examination is completed. This could result in  a delay with procedure  and/or  potential damage to the patients blood vessels due to removal without visibility.

## Distribution

US Nationwide distribution including in the states of LA, CA, CO, WV, GA, NH, FL, PA, WI, MN, ID.

## Key facts

- **Recall number:** Z-0532-2021
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-08
- **Report date:** 2020-12-09
- **Termination date:** 2022-12-06

- **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-0532-2021

## Citation

> AI Analytics. FDA recall Z-0532-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0532-2021. Source: US FDA. Licensed CC0.

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