BEUDAMED
    FDA Enforcement Class II Ongoing

    p-Chip Wand Reader

    Recall: Z-1693-2023 · Reported June 21, 2023

    Enforcement

    Recall Number
    Z-1693-2023
    Event ID
    92483
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    p-Chip Corporation
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    June 21, 2023
    Initiation Date
    March 3, 2021
    Classification Date
    June 12, 2023
    Address
    500 W Madison St, Suite 1000, Chicago, IL, 60661-4544, United States

    Description

    p-Chip Wand Reader

    Reason

    The laser operation might fall under a higher laser class.

    Code Info

    Model: WA-4000, 4500, -8000, and -8500

    Distribution

    US Nationwide Distribution

    Quantity

    329 units