BEUDAMED
    FDA Enforcement Class I Ongoing

    KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the upper limb on one side of the body.

    Recall: Z-0049-2025 · Reported October 23, 2024

    Enforcement

    Recall Number
    Z-0049-2025
    Event ID
    95065
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Kinova Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 23, 2024
    Initiation Date
    August 22, 2024
    Classification Date
    October 11, 2024
    Address
    355 Peel St Suite 301, Montreal, N/A, Canada

    Description

    KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the upper limb on one side of the body.

    Reason

    Potential installation issue that could result in a fire hazard in the event of an interaction between a damaged Jaco arm and a wheelchair exhibiting electrical leakage.

    Code Info

    Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. All lot numbers.

    Distribution

    Worldwide - US Nationwide distribution in the states of California, Missouri, North Carolina, Ohio and the countries of Australia, Canada, China, Czechia, France, Germany, Netherlands, Norway, Portugal, Switzerland, Great Britain, Northern Ireland.

    Quantity

    949 units