This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
- Product Name: AutoPulse NXT Platform
- Model: Model 200
- Catalog Number: 8700-001070-1
- Software Version: Version 2.0.1
Full List of Affected Devices
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What to Do
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.
Reason for Recall
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.
At this time, there have been no reported injuries or deaths related to this issue.
Device Use
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.
Contact Information
Customers in the U.S. with questions about this recall should contact ZOLL Circulation, Inc. at 408-541-2140.
Additional FDA Resources (listed in order of most to least recent):
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
