Zoll is recalling the AutoPulse Nxt Resuscitation System due to a failure code that may cause the device to stop delivering chest compressions or fail to compress deeply enough, according to an FDA alert.
Zoll Circulation Inc is recalling the AutoPulse Nxt Resuscitation System due to a failure code (FC1060), which indicates an error in the correct determination of compression depth. As a result, compressions may stop or compressions may not be deep enough, delaying life-saving cardiopulmonary resuscitation (CPR).
The use of affected product may cause serious adverse health consequences, including reduced blood flow to vital organs, brain injury from lack of oxygen (anoxic brain injury), and death, the FDA reports.
No injuries or deaths have been reported, according to the alert.
The AutoPulse Resuscitation System Model 200 is an automated, portable, battery-powered device designed to assist with manual CPR. It is intended for use on adult patients experiencing clinical death, defined as the absence of spontaneous breathing and pulse. The device should be used only when chest compressions are likely to benefit the patient.
FDA Recommendations
On March 4, 2025, Zoll Circulation Inc sent all affected customers an Urgent Medical Device Recall Notice recommending the following actions:
- Immediately discontinue use of any affected AutoPulse Nxt device.
- Return affected devices to Zoll as soon as they receive their loaner platform.
- Zoll will remove and replace the out-of-spec center pulley assembly, then perform final functional tests on the repaired platform per the approved standard repair procedure.
Affected Product
- Product Name: AutoPulse Nxt Platform
- Model: Model 200
- Catalog Number: 8700-001070-1
- Software Version: Version 2.0.1
