# FDA recall Z-0198-2023

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2022-09-29.

## Product

Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CUS-AA450

## Reason for recall

After completion, ultrasound system's Stress Echo may not terminate if user does not manually terminate the protocol. During next patient exam, an abnormal confirmation message will be displayed "Same view was saved in this phase. Do you use this image with StressEcho Review?" If "no", acquired images not saved, and if "yes" images assigned to the previous patient; could cause treatment delay.

## Distribution

US: MT, MO, NC, SC, MN, WA, KY, TN, AR, IL, IA, MI, WV, KS, CA, HA, CO, LA, OK, ME, KY, NY, PA, GA, FL

## Key facts

- **Recall number:** Z-0198-2023
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-29
- **Report date:** 2022-11-16

- **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-0198-2023

## Citation

> AI Analytics. FDA recall Z-0198-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0198-2023. Source: US FDA. Licensed CC0.

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