Canon Aplio ultrasound system — Class II medical device recall Z-0198-2023
Ongoing recall by Canon Medical System, USA, INC., reported 2022-11-16, distributed in AR, CA, CO, FL, GA, IA, IL, KS…. After completion, ultrasound system's Stress Echo may not terminate if user does not manually terminate the pr
| Recall number | Z-0198-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canon Medical System, USA, INC., Tustin, CA, United States |
| Recall initiated | 2022-09-29 |
| Classified | 2022-11-07 |
| Reported by FDA | 2022-11-16 |
| Distributed | AR, CA, CO, FL, GA, IA, IL, KS, KY, LA, ME, MI, MN, MO, MT, NC, NY, OK, PA, SC, TN, WA, WV |
| Quantity | 65 |
| UPC / GTIN / UDI-DI | 04987670102509, 04987670102516, 04987670102523, 04987670103346, 04987670103353 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0198-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.