# FDA recall Z-1721-2020

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2019-03-25.

## Product

Canon Aquilion Premium, Model TSX-301B

## Reason for recall

Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot.  Loss of the acquired raw data would occur.

## Distribution

Distribution was made to AK, AR, CA, FL, IA, ID, IL, KS, MA, MD, MI, MN, MO, MT, NC, ND, NH, NY, OH, OK, OR, PA, TN, TX, VT, WA, WI, and WV.  There was government and military distribution but no foreign distribution.

## Key facts

- **Recall number:** Z-1721-2020
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-03-25
- **Report date:** 2020-04-22

- **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-1721-2020

## Citation

> AI Analytics. FDA recall Z-1721-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1721-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*