BEUDAMED
    FDA Recall 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 · Initiated July 19, 2019

    Recall

    Recall Number
    Z-2495-2019
    Event Number
    83560
    Firm
    Philips North America, LLC
    FEI Number
    1218950
    Product Code
    DSA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 19, 2019
    Terminated
    June 3, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    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.

    Action

    Philips sent a Customer Information letter dated July 2019 to affected customers. The letter identified the affected product, problem and actions to betaken. Customers were instructed to: 1. To identify all affected limb lead sets. 2. To fill-out, sign and send a reply form that is provided. 3. To discard affected limb lead sets following approved medical waste disposal methods per facility and/or local regulations. 4. Do not return any affected product to Philips if you need any further information or support concerning this issue, please contact your local Philips representative.

    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)