BEUDAMED
    FDA Recall Terminated

    Model M4735A HeartStart XL Defibrillator//Monitor

    Recall: Z-1226-03 · Initiated September 2, 2003

    Recall

    Recall Number
    Z-1226-03
    Event Number
    27134
    Firm
    Philips Medical Systems
    FEI Number
    1218950
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 2, 2003
    Posted
    September 11, 2003
    Terminated
    April 20, 2005
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Model M4735A HeartStart XL Defibrillator//Monitor

    Reason

    Instructions For Use include addtional information on configuration for selecting Power on Lead

    Action

    Philips Medical in conjunction with NNC (National Notification Center) notified users by letter on 9/2/03. Users are provided with Addendum to the HeartStart XL Instructions for Use (to be added to the Instruction for Use) and to familiarize with the configurable Power on Lead. Users are rquested to acknowledge receipt by returning the Business reply Card.

    Distribution

    NATIONWIDE Foreign: Canada, Argentina, Brazil, Chile, Costa Rica, Mexico, Paraguay, Peru, Venezuela, Austalia, China,Hong Kong, India, Japan, Malaysia, Manilla, New Zealand, Manila, Singapore,Taiwan,Thailand, Vietnam, ALgeria, Australia,France,Italy, Netherlands,Norway,Oman,Poland, Portugal,South Africa, Spain, Sri Lanka, Sweden, Switzerland, Tunisia, Turkey, UK

    Quantity

    16,736 units