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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices

AutoPulse NXT Resuscitation System Recalled for Potential Failure to Compress

Agency Publication Date: April 11, 2025
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Summary

Approximately 91 units of the AutoPulse NXT Resuscitation System (Model 200) are being recalled because the device may fail to provide adequate chest compressions or stop compressions entirely due to a system error (code FC1060). This automated, battery-powered CPR device is used as an adjunct to manual CPR on adults. Because the failure can occur during a life-saving procedure, any interruption in compressions poses a significant risk to the patient. No injuries or deaths have been reported to date.

Risk

The device may stop providing chest compressions or provide inadequate compressions, which could delay or interrupt critical resuscitation efforts for patients in cardiac arrest. This malfunction could lead to serious injury or death if the patient does not receive consistent and effective chest compressions.

What You Should Do

  1. This recall involves the AutoPulse NXT Resuscitation System (Model 200, Catalog Number 8700-001070-1) running software version 2.0.1.
  2. Identify if your device is affected by checking the UDI (00849111003384) and the serial number on the product label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately to ensure patient safety.
  4. Contact ZOLL Circulation, Inc. or your authorized medical distributor to arrange for a return, replacement, or device correction.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for further information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: AutoPulse NXT Resuscitation System Model 200
Variants: Software Version 2.0.1
Model / REF:
Model 200
8700-001070-1
Serial Numbers (79):
1179
1168
1178
1184
1188
1197
1109
1110
1126
1166
1169
1152
1199
1202
1111
1185
1198
1203
1206
1208
1211
1212
1172
1182
1130
1128
1129
1189
1183
1131
1134
1191
1186
1192
1170
1173
1175
1180
1174
1176
1187
1177
1116
1165
1118
1119
1193
1138
1139
1145
UDI:
00849111003384

Automated portable battery powered device for adult chest compressions.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96479
Status: Active
Manufacturer: ZOLL Circulation, Inc.
Sold By: Authorized Medical Distributors; ZOLL Sales Representatives
Manufactured In: United States
Units Affected: 91
Distributed To: Alabama, California, Connecticut, Florida, Illinois, Kansas, Louisiana, Minnesota, Missouri, Montana, North Carolina, North Dakota, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.