BEUDAMED
    FDA Enforcement Class II Ongoing

    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

    Recall: Z-0198-2023 · Reported November 16, 2022

    Enforcement

    Recall Number
    Z-0198-2023
    Event ID
    90980
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Canon Medical System, USA, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 16, 2022
    Initiation Date
    September 29, 2022
    Classification Date
    November 7, 2022
    Address
    2441 Michelle Dr, N/A, Tustin, CA, 92780-7047, United States

    Description

    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.

    Code Info

    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

    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

    Quantity

    65