# FDA recall Z-0549-2021

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2020-11-09.

## Product

Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.

## Reason for recall

A software problem has been identified  which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing  resulting in rescanning and reinjection of contrast medium.

## Distribution

US Nationwide distribution. OUS: Unknown

## Key facts

- **Recall number:** Z-0549-2021
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-09
- **Report date:** 2020-12-16
- **Termination date:** 2022-12-16

- **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-0549-2021

## Citation

> AI Analytics. FDA recall Z-0549-2021. Retrieved 2026-07-31 from https://api.ai-analytics.org/recall/Z-0549-2021. Source: US FDA. Licensed CC0.

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