BEUDAMED
    FDA Recall Open, Classified

    Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. Component: N/A

    Recall: Z-1533-2025 · Initiated March 4, 2025

    Recall

    Recall Number
    Z-1533-2025
    Event Number
    96479
    Firm
    ZOLL Circulation, Inc.
    FEI Number
    3003793491
    Product Code
    DRM
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    March 4, 2025
    Posted
    April 11, 2025
    Address
    2000 Ringwood Ave, San Jose, CA, 95131-1728

    Description

    Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 8700-001070-1) Software Version: Version 2.0.1 Product Description: The AutoPulse Resuscitation System Model 200 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. Component: N/A

    Reason

    AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.

    Action

    On March 4, 2025, Zoll Circulation issued a "Medical Device Product Correction Notice" to affected consignees. Zoll asked consignees to take the following actions: 1. Stop using your affected platform(s) immediately. Your patients may not receive high-quality compressions. 2.Complete the Customer Acknowledgment/ No-Charge AP NXT Platform Repair Request Form (page 3)and email it to [email protected] within 3 days. Please feel free to call me at (408) 419 - 2955 if you have any questions. 3.Return your affected platform(s) to ZOLL as soon as you receive the loaner AP NXT Platform(s) from ZOLL.

    Distribution

    US: AL, CA, CT, FL, IL, KS, LA, MN, MO, MT, NC, ND, NM, NY, OH, OK< PA, TX, WI OUS: Canada, Hong Kong,

    Quantity

    91