PlainRecalls
FDA Devices Critical Class I Ongoing

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

Reported: April 23, 2025 Initiated: March 4, 2025 #Z-1533-2025

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

Reason for Recall

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

Details

Recalling Firm
ZOLL Circulation, Inc.
Units Affected
91
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,
Location
San Jose, CA

Frequently Asked Questions

What product was recalled?
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. Recalled by ZOLL Circulation, Inc.. Units affected: 91.
Why was this product recalled?
AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 23, 2025. Severity: Critical. Recall number: Z-1533-2025.