Device Recall: ZOLL AutoPulse NXT Resuscitation System

Urgent Class I Medical Device Recall

ZOLL Circulation, Inc. has issued a Class I recall of its AutoPulse NXT Resuscitation System (Model 200, Software Version 2.0.1) due to a system error that may cause the device to stop chest compressions or deliver compressions that are too shallow.

Device Use

The AutoPulse NXT is a battery-powered CPR device used on adults with no pulse or spontaneous breathing. It automates chest compressions and is intended for emergency use when CPR is needed.

What’s the Problem?

A failure code (FC1060) in the AutoPulse NXT prevents the device from correctly measuring compression depth. This could result in interrupted or inadequate CPR, posing serious risks such as:

• Reduced blood flow to vital organs
• Anoxic brain injury (due to lack of oxygen)
• Death

No injuries or deaths have been reported so far.

Affected Devices

• Product: AutoPulse NXT Platform
• Model: 200
• Catalog Number: 8700-001070-1
• Software Version: 2.0.1

A full list of affected devices follows this post.

What You Should Do

Zoll’s March 4, 2025 Urgent Medical Device Recall Notice advises:

• Immediately stop using any affected AutoPulse NXT units
• Return devices to ZOLL upon receipt of a loaner platform
• ZOLL will repair and retest devices by replacing the faulty center pulley assembly

Questions?

Contact ZOLL Circulation, Inc. at 408-541-2140 for more information.

Read the FDA recall warning here.

See recent device recalls here. 

Affected Devices