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RecallWatchMedical Device Safety
Class IOngoingZ-1533-2025

ZOLL Circulation, Inc. recalls Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform M…

ZOLL Circulation, Inc.San Jose, CA, United StatesReported Apr 23, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    79 affected lots
    11791168117811841188119711091110
    +71 more11261166116911521199120211111185119812031206120812111212117211821130112811291189118311311134119111861192117011731175118011741176118711771116116511181119119311381139114511461147114811491150115311551159116111621163116411811141110811901195112011211122112311071112111311141115113711401196

What the firm is doing

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 dlam@zoll.com 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.

DistributionShow details

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

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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