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U.S. Department of Health and Human Services

Class 1 Device Recall AutoPulse NXT Resuscitation System

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 Class 1 Device Recall AutoPulse NXT Resuscitation Systemsee related information
Date Initiated by FirmMarch 04, 2025
Date PostedApril 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1533-2025
Recall Event ID 96479
510(K)NumberK221700 
Product Classification Compressor, cardiac, external - Product Code DRM
ProductBrand 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
Code Information UDI: (01) 00849111003384/Serial number: 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 1146 1147 1148 1149 1150 1153 1155 1159 1161 1162 1163 1164 1181 1141 1108 1190 1195 1120 1121 1122 1123 1107 1112 1113 1114 1115 1137 1140 1196
FEI Number 3003793491
Recalling Firm/
Manufacturer		 ZOLL Circulation, Inc.
2000 Ringwood Ave
San Jose CA 95131-1728
For Additional Information Contact
408-541-2140
Manufacturer Reason
for Recall		AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
FDA Determined
Cause 2		Process change control
ActionOn March 4, 2025, Zoll Circulation issued a "Medical Device Product Correction Notice" to affected consignees. Zoll asked consignees to take the following actions: 1. Stop using your affected platform(s) immediately. Your patients may not receive high-quality compressions. 2.Complete the Customer Acknowledgment/ No-Charge AP NXT Platform Repair Request Form (page 3)and email it to dlam@zoll.com within 3 days. Please feel free to call me at (408) 419 - 2955 if you have any questions. 3.Return your affected platform(s) to ZOLL as soon as you receive the loaner AP NXT Platform(s) from ZOLL.
Quantity in Commerce91
DistributionUS: AL, CA, CT, FL, IL, KS, LA, MN, MO, MT, NC, ND, NM, NY, OH, OK< PA, TX, WI OUS: Canada, Hong Kong,
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DRM
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