ZOLL Circulation, Inc.: Device Recall

Recall #Z-1533-2025 · 03/04/2025

Class I: Dangerous

Recall Details

Recall Number
Z-1533-2025
Classification
Class I
Product Type
Device
Recalling Firm
ZOLL Circulation, Inc.
Status
Ongoing
Date Initiated
03/04/2025
Location
San Jose, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
91

Reason for Recall

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

Product 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

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,

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.