FDA Device recall Z-0198-2023
Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CU…
- FDA Device
- Class II
- ongoing
- Published 2022-11-16
On 2022-11-16 the FDA classified a Class II recall of Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CU… by Canon Medical System Usa, citing 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 wi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0198-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-29 |
| Published | 2022-11-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Canon Medical System Usa |
| Distribution | AR, CA, CO, FL, GA, IA, IL, KS, KY, LA, ME, MI, MN, MO, MT, NC, NY, OK, PA, SC, TN, WA, WV |
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
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.
Identifiers
| code_info | Model/UDI-DI, with software: Aplio i900 TUS-AI900/ 04987670102523, Aplio i800 TUS-AI800/ 04987670102516, Aplio i700 TUS…Model/UDI-DI, with software: Aplio i900 TUS-AI900/ 04987670102523, Aplio i800 TUS-AI800/ 04987670102516, Aplio i700 TUS-AI700/ 04987670102509, With System Version:V4.6/V5.0/V5.1, SP0005 to SP1014, or V6.0/V6.5 SP0000 to SP1009; Aplio a550 CUS-AA550/ 04987670103353, Aplio a450 CUS-AA450/ 04987670103346, With System Version: V3.0, SP0005 to SP1014, or V4.0/V4.5, SP0000 to SP1009 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0198-2023%22
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