ZOLL Circulation, Inc. recalls Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform M…
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/A79 affected lots11791168117811841188119711091110
+71 more
11261166116911521199120211111185119812031206120812111212117211821130112811291189118311311134119111861192117011731175118011741176118711771116116511181119119311381139114511461147114811491150115311551159116111621163116411811141110811901195112011211122112311071112111311141115113711401196
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 detailsHide
US: AL, CA, CT, FL, IL, KS, LA, MN, MO, MT, NC, ND, NM, NY, OH, OK< PA, TX, WI OUS: Canada, Hong Kong,
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1533-2025
- FDA 510(k) clearance · K221700The device's official FDA premarket clearance record
- FDA device classification · DRMOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.5200The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find ZOLL Circulation, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
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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