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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

FDA Recall Z-1533-2025 · Posted 2025-04-11

Recalling FirmZOLL Circulation, Inc.
Recall StatusOpen, Classified
Product CodeDRM
Date Initiated2025-03-04
Product Quantity91

Reason for Recall

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

Firm 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.

Root Cause

Process change control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K221700AutoPulse NXT Resuscitation SystemZoll Circulation, Inc. · 2023-03-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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