BEUDAMED
    FDA Enforcement Class II Terminated

    Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration

    Recall: Z-2495-2019 · Reported September 18, 2019

    Enforcement

    Recall Number
    Z-2495-2019
    Event ID
    83560
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2019
    Initiation Date
    July 19, 2019
    Classification Date
    September 9, 2019
    Termination Date
    June 3, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration

    Reason

    The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. which may prevent or impede the performance of I 2-Lead ECG measurements.

    Code Info

    Lot codes: 03/18, 05/18 and 06/18

    Distribution

    Worldwide Distribution - US Nationwide State KY AZ CA UT OH NY SC CO FL IN TX ND KS GA Canada Germany

    Quantity

    280 boxes ( 5600 leadsets)