BEUDAMED
    FDA Enforcement Class II Ongoing

    Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system

    Recall: Z-0183-2023 · Reported November 16, 2022

    Enforcement

    Recall Number
    Z-0183-2023
    Event ID
    90954
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    iRhythm Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 16, 2022
    Initiation Date
    September 28, 2022
    Classification Date
    November 4, 2022
    Address
    6550 Katella Ave, N/A, Cypress, CA, 90630-5102, United States

    Description

    Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system

    Reason

    Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notifications delayed until patient registration is complete; 2) Patches limited to 100 symptomatic and 500 asymptomatic wireless transmissions; once the maximum transmission limit is reached for either type, any further transmissions for that type will cease. Risk of delayed reporting to health providers.

    Code Info

    UDI-DI: 00869770000210; Model/Revision: ALB0031/07, ALB0034/03

    Distribution

    US: MD, NY, FL, TN, WA, AL, MA, AZ, CA, KS, HI, PA, NJ, TX, MN, VA, AR, OR, NC, CO, KY, MS, LA, MI, WI, WV, IN, ID, SC, CT, SD, IA, NV, OK, OH, IL, VT, NH, NE, NM, MO, ME, DC, RI, MT, DE, GA, ND

    Quantity

    1,443